Clinical Trials

Study: NCCTG N0577,
“Phase III Randomized Study of Radiotherapy Alone Versus Radiotherapy With Concurrent and Adjuvant Temozolomide Versus Temozolomide Alone in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Glioma.”
 
This research study is being done for people who have a certain type of brain tumor, called “anaplastic glioma.”  In addition, some of the tumor cells must also be missing parts of chromosomes 1 and 19.  These chromosomes are missing parts only in the tumor cells, and are not typically missing in the normal body cells.  This type of anaplastic glioma has a more favorable outcome than other types of anaplastic glioma.  Standard therapy at this point in time is surgery followed by radiation therapy.
 
The two main reasons this research study is being done are to see if:
 
• people have longer survival if they get treatment with the combination of both radiation therapy and temozolomide chemotherapy as compared to people who receive treatment with radiation therapy alone.
• people treated with temozolomide therapy alone (no radiation therapy) have a better or worse quality of life and mental function than those subjects who are treated with either the combination of radiation therapy and temozolomide or radiation therapy alone.  Survival will also be monitored in the people getting temozolomide alone.
 
The tumor has "switches" that turn on tumor cell growth and division.  These two drugs may prevent two of the main switch pathways in the tumor cells from working properly, which hopefully might prevent the cells from growing.  This is what the research study will attempt to answer.
 
Sorafenib and CCI-779 are experimental (investigational) drugs for your disease.  An investigational drug is one which has not been approved for this use by the U.S. Food and Drug Administration (FDA).  The drugs are approved for use in other conditions.
 
Study: RTOG 1122
“Phase II Double-Blinded Placebo-Controlled study of Bevacizumab with or without Amg 386 in Patients with recurrent Glioblastoma or Bliosarcoma." 
 
The purpose of this study is to find out the effect of bevacizumab with or without a new investigational drug, AMG 386, on brain tumors. Bevacizumab is a protein that works by preventing new cancer-related blood vessel formation.  The U.S. Food and Drug Administration (FDA) has approved bevacizumab for the treatment of recurrent glioblastoma. However, treatment with bevacizumab alone has only modestly improved overall survival in patients with this type of brain tumor.  For this reason, other drugs, such as AMG 386, are being evaluated.  It is hoped that AMG 386 will kill tumor cells and that it may also block blood vessels that supply the tumor in the brain with nutrients and oxygen.
 
BREAST CANCER STUDIES:
 
"A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer"
 
Purpose: The standard treatment for metastatic breast cancer is the use of chemotherapy, anti-hormone pills, or other medication.  When the cancer is no longer only in the breast and has spread to other areas of the body, surgery and/or radiation for the tumor in the breast cannot control the other areas of the cancer and are only used if the breast tumor is causing skin breakdown or pain, which happens only in some patients.  For most people, the tumor in the breast is controlled with medicine and does not cause problems.  We do not know if local treatment (surgery and/or radiation) used early in the course of treatment of the breast cancer will help patients with metastatic breast cancer live longer or not. 
 
The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the breast tumor to the standard approach of continued treatment with the medication which is working to control the tumor.  In this study, patients will get either surgery plus radiation to the breast, or continue with the best medical treatment advised by the  study doctor. Patients who receive the standard treatment, but the medicine is no longer controlling the tumor in the breast, and the doctor feels surgery or radiation is needed, patients may receive this.
 
 
Study: NSABP B-43    
"A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy"
 
Purpose:  This study is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy.  Radiation therapy is the standard treatment for patients with DCIS.
 
  • This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.
 
The drug trastuzumab is called a targeted therapy because it targets breast cancers that make too much of a protein called HER2.  These cancers are called HER2-positive.  Too much of the HER2 protein can cause cells to receive extra growth signals.  This can turn a normal cell into a cancer cell and can cause cancer cells to grow faster.
 
Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2-positive “invasive” breast cancers.  (“Invasive” means the cancer has spread outside the milk ducts into other parts of the breast or to other parts of the body.)
 
Also, there is early information that suggests trastuzumab may be a “radiosensitizer”.  This means that trastuzumab may help radiation therapy work better in HER2-positive breast cancer.  More research is needed to prove this.
 
In this study, trastuzumab is considered to be investigational (still being researched) because it has not yet been approved by the U.S. Food and Drug Administration (FDA) or Health Canada for use in the treatment of DCIS.
 
  • The only research data on how trastuzumab affects the ovaries in women who have not yet gone through menopause are from studies of trastuzumab given with chemotherapy or after chemotherapy.  This study will learn if trastuzumab given without chemotherapy affects the ovaries in women who have not yet gone through menopause.
 
  • Those who join the study, will have special research tests done on their tumor tissue that was removed at the time of their lumpectomy.  The results of these tests should provide NSABP researchers with information about how genes in the cancer cells may affect the way HER2-positive DCIS responds to treatment.
 
Study: NSABP B-47
"A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone
(Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus
Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast
Cancer."
 
Purpose:  To learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.
 
Trastuzumab is called a targeted therapy because it targets the tumor cells by blocking the HER2 protein on the surface of the cancer cell to slow down or stop cancer growth.  Trastuzumab is a standard treatment for HER2-positive breast cancer.  In this study, trastuzumab is considered to be investigational because it has not been studied for use in treating HER2-low breast cancer.  Investigational means that trastuzumab has not been approved by the U.S. Food and Drug Administration (FDA) for this use.
 
Studies that already have been done with trastuzumab focused on breast cancers that were strongly HER2-positive.  However, in some of these studies, tumor samples were checked in a central laboratory to confirm the HER2 testing results.  Some breast cancers that were thought to be HER2-positive were actually HER2-low.  The researchers then looked at the results of treatment in subjects with HER2-low tumors.  They found that trastuzumab seemed to have benefit in keeping the cancer from returning even when the HER2 levels were in the normal range.  This study is being done to learn more about using trastuzumab to treat HER2-low breast cancer.
 
  • A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer.
 
  • In order to learn more about certain characteristics of cancer tumors, this study includes special research tests that will be done on samples of the tumor that were removed during surgery for breast cancer and on blood samples that will be collected during the study.  
 
  • Another goal of this study is to find out how the study drugs used in this study affect menstrual cycles (monthly periods) and if these changes in menstrual cycles have any effect on breast cancer. As part of this study goal, blood samples will be collected.
 
• This study will also explore the possibility that other medical conditions, medications the patient may be taking, or other factors such as alcohol intake, smoking, and weight may affect breast cancer.  The patient will be asked to complete questionnaires and allow blood samples to be taken to help answer these questions.
 
Study: NSABP B-49
"A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer"
 
Purpose: This study is being done for women who have early stage breast cancer that has been removed by surgery.  Chemotherapy and other therapy after surgery will decrease the chance of this cancer returning.  This study is only for women with HER2-negative breast cancer.  This means that the tumor cells do not have extra HER2 protein on their surfaces. 
 
This study is being done for the following reasons:
  •  This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating this type of breast cancer.  All of these drugs are used in standard combinations of chemotherapy for breast cancer.
  • The researchers also want to learn about the side effects of the combinations of drugs used in this study.  Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
  • In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during breast cancer surgery. 
Study: NSABP B50-I
“A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients with HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy”
 
Purpose: The purpose of this study is to compare the effects, good or bad, of trastuzumab emtansine versus trastuzumab (Herceptin®) on breast cancer to find out which is better.  In this study, participants will get either trastuzumab emtansine or trastuzumab alone.  Trastuzumab emtansine is an experimental drug, which means that health authorities have not approved trastuzumab emtansine for the treatment of HER2-positive primary non-metastatic breast cancer. Eligible participant in this study must have HER2-positive primary non-metastatic breast cancer and have evidence of cancer in the breast and lymph nodes after chemotherapy and trastuzumab.
  
“A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy”
 
Purpose: 
For women with breast cancer who do not have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast only after lumpectomy and not at all after mastectomy.  For women with breast cancer who do have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast and lymph nodes after lumpectomy; and after mastectomy, radiation is usually given to the area where the breast used to be and to the lymph nodes.
 
The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes.  This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping breast cancer from returning, and 2) if, after mastectomy, radiation to the area where the breast used to be and to the lymph nodes is better than no radiation at keeping breast cancer from returning.  This study also asks whether giving radiation as described above will help women live longer. 
 
Study: SCCA 6628
“Combined Targeted Therapies for Triple Negative Advanced Breast Cancer – A Phase II
Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted 
Therapy with Bevacizumab and Erlotinib”
 
Purpose: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab work when followed by bevacizumab and erlotinib in treating patients with metastatic breast cancer.
 
Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with bevacizumab and erlotinib may kill more tumor cells.
 
Study: SWOG S1007
"A phase III, randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and her2-negative breast cancer with recrurrence score (RS) of 25 or less"
 
Purpose: The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not.This study is being done in subjects with lower Recurrence Scores (25 or less).
 
Currently most women who have this kind of breast cancer are treated with endocrine therapy (treatment that works with hormones).  Many women also receive emotherapy.  No one really knows which patients with lower Recurrence Scores need to get chemotherapy.  Some women may be getting chemotherapy who do not need it.  These women may be exposed to side effects of their treatment that are not a necessary risk in relation to the benefit they receive.
 
If the results of the study show that the benefit for getting chemotherapy is dependent on the Recurrence Score, the study should be able to identify a Recurrence Score level where chemotherapy should be considered (and a recurrence score level where chemotherapy may not be needed).
 
Study: SWOG S1207
“Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer”
 
Purpose: The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without the cancer returning.  The current standard treatment after chemotherapy is hormone treatment alone.  Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer.  It is considered investigational for breast cancer patients.  In this study participants will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.
   
GASTROINTESTINAL CANCER STUDIES -- No studies at this time.  Please check back again. 
 
SWOG S0702 - See below under Miscellaneous Studies
 
URCC 10055 - See below under Miscellaneous Studies
 
GENITOURINARY CANCER STUDIES:
 
Study: CTSU C90203 (Prostate) 
"A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation  Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with  High-Risk, Clinically Localized Prostate Cancer."
 
Purpose: The purpose of this study is to compare the effects (good and bad) of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove the prostate) with radical prostatectomy alone in patients with high-risk prostate cancer to see which is better.
 
This research is being done because many men with this type of prostate cancer are at risk of having the cancer come back if they are treated only with surgery.  The study is trying to find out if giving chemotherapy with hormone therapy before surgery makes the chance of being cured of prostate cancer better.
 
The study will also assess whether diet or lifestyle predicts how well men do overall with this type of cancer.
 
Study: RTOG 0924 (Prostate)
"Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer:  A Phase III Randomized Trial"
 
Purpose: The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area on patients and their prostate cancer to find out which is better.  There are 2 treatment groups in this study:
* Subjects who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles (two small glands behind the prostate)
* Subjects who receive hormone therapy plus radiation therapy to the whole pelvis
  
Study: SWOG S0702 - See below under miscellaneous studies
 
GYNECOLOGICAL CANCER STUDIES
 
“A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers”
 
Purpose: 
The purpose of this study is to see if paclitaxel and carboplatin (chemotherapy drugs) plus AMG 386, followed by 18 months of AMG 386 after the chemotherapy, will have an improved outcome compared to paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo after the chemotherapy.  The study will include women with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancers.
 
AMG 386 is a man-made medication designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
 
AMG 386 is considered experimental (or investigational). AMG 386 is not approved by any regulatory organization (such as the Food and Drug Administration (FDA) in the United States, or the European Medicines Agency (EMA) in Europe) to treat any type of cancer. Therefore, AMG 386 is not approved to treat subjects who have been diagnosed with recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer.
 
The AMG 386 placebo will look like and be administered in the same way as the AMG 386 but it will not contain active ingredients.
 
Study: GOG 0213 (Ovarian) 
"A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone r in Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer"
 
PURPOSE:  One purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone.  Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life (wellness and physical functioning).
 
The second purpose of this study is to determine if a second surgery to remove tumor followed by chemotherapy can increase the time that patients remain disease free.  If the study doctors feel that their patients are good candidates for the second surgery they will be randomized to have surgery or not and at the same time they will be randomized to receive one of the two possible chemotherapy combinations.
 
Randomization means that participants are put into a group by chance. A computer program will place them in one of the study groups.  Neither the participants nor their study doctor can choose the group they will be in.  Participants will have an equal chance of being placed in either group.  If they are not eligible for surgery they can still be randomized to receive chemotherapy.  If participants are randomized to receive the surgery it will be performed before they are given chemotherapy. Chemotherapy will not be given until participants recover from the surgery which could take up to six weeks.
 
Study: GOG 0258 (Endometrial)
“A Randomized Phase III Trial Of Cisplatin And Tumor Volume Directed Irradiation Followed By Carboplatin And Paclitaxel Vs. Carboplatin And Paclitaxel For Optimally Debulked, Advanced Endometrial Carcinoma”
 
Purpose: 
Patients with endometrial cancer have been treated with radiation and chemotherapy.  Today most women whose endometrial cancer has spread outside the uterus receive chemotherapy.  Women who have disease outside the uterus may also receive radiation in the areas where the disease has spread.  It is not clear whether giving chemotherapy alone or together with radiation is the best treatment.  This study is being done to see if radiation therapy together with chemotherapy administered for a total of 4 cycles offers benefit over chemotherapy alone administered over 6 cycles.
 
The current study will compare the effects of two treatments in subjects with endometrial cancer.  One treatment which is considered investigational consists of cisplatin given together with radiation therapy followed by the drugs carboplatin and paclitaxel for 4 cycles.  Another treatment, the current standard therapy, consists of carboplatin and paclitaxel given for 6 cycles without radiation therapy.  This study will compare survival of subjects and side effects receiving these two study treatments.  Participants will be given only one of these study treatments.
 
HEAD and NECK CANCER STUDIES
-- No studies at this time.  Please check back again

LEUKEMIA CANCER STUDIES:
-- No studies at this time.  Please check back again. 

LUNG CANCER (NON-SMALL CELL) STUDIES:
 
Study: SWOG S0819
“A Randomized, Phase III Study comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer”
 
Purpose: The purpose of this study is to compare the effects, good and/or bad, of cetuximab on lung cancer, in combination with other chemotherapy.
 
The participant will be “randomly assigned” to receive either chemotherapy without cetuximab or chemotherapy with cetuximab.  Random assignment means that participants are put into a group by chance.  A computer program will place you in one of the study groups. Neither participants nor the study doctor can choose the group you will be. However, this information is available to the study doctor if needed in an emergency. The participant will have an equal chance of being placed in either group to receive cetuximab or not (Groups 3 and 4 for cetuximab).  The decision about whether the participant will receive bevacizumab will be made by the participant and their study doctor based on several considerations related to their health history.
 
LUNG CANCER (SMALL CELL) STUDIES:
-- No studies at this time.  Please check again.
 
LYMPHOMA (NON-HODGKIN’S) STUDIES:
 
Study: SWOG S1001
"A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)"
 
Purpose: Limited (or early) Stage Diffuse Large B-cell Lymphoma is curable in many people, but some still relapse, and some develop side-effects after this treatment.  This study uses a radiologic test called PET/CT scan to determine treatment after initial doses of a standard chemotherapy called "R-CHOP" (the drugs doxorubicin, cyclophosphamide, vincristine, prednisone and rituximab).  Although all of the agents used in this study are FDA approved, the purpose of the study is to give more intensive treatment to patients whose PET/CT scan shows that they are at a greater chance of still having active lymphoma, and to give less intensive treatment to subjects whose PET/CT scan shows that they have a smaller chance of still having active lymphoma. In this way, we hope to improve the cure rate for all patients while decreasing the side effects of the treatment. 
 
Researchers would also like to request the leftover tissue from the original biopsy to study the biology of stage I/II Diffuse Large B-cell lymphoma.   Participants will also have the option to submit blood samples for research purposes only. 
 
Study URCC 10055 - See below under miscellaneous studies
Study SWOG S0702 - See below under miscellaneous studies
 
LYMPHOMA (HODGKIN’S DISEASE) STUDIES:
--
No studies at this time. Please check again.
 
MELANOMA CANCER STUDIES:
-- No studies at this time.  Please check again.
 
MYELOMA STUDIES:
 
Study SWOG S0702 - See below under miscellaneous studies.
 
SARCOMA STUDIES:
 -- No studies at this time.  Please check back again. 

MISCELLANEOUS STUDIES:
 
Study: SWOG S0702
“A prospective observational multicenter cohort study to assess the incidence of osteonecrosis of the jaw (ONJ) in cancer patients with bone metastases starting zoledronic acid treatment. ”
 
Purpose: The purpose of this study is to learn how often ONJ occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment.  This study will also identify risk factors associated with ONJ.
 
Zoledronic acid falls under a category of drugs called bisphosphonates.  Bisphosphonates are sometimes given to patients who have cancer that has spread to their bones because it can lower the chances of getting fractures and reduces bone pain.  Usually, zoledronic acid is well tolerated by patients, but there has been an increase in the number of reported cases of osteonecrosis of the jaw (ONJ).  Symptoms associated with ONJ are swelling of the soft tissue around the jaw, infection, loosening of teeth, drainage, and exposed jaw bone.  There is concern about the association of ONJ with bisphosphonate therapy.
 
Study: URCC 10055 (Cognitive Study)
“Study of Cognitive Function of Patients With Breast Cancer or Lymphoma Receiving Chemotherapy.”
 
Purpose: many cancer patients report mild to moderate cognitive difficulties (such as problems remembering things, multi-tasking, or concentrating) during and following treatment of their cancer and currently we do not have very good treatments for these difficulties. We also do not know what may be causing these difficulties.
 
This study is being conducted to better understand how common these cognitive difficulties are by using cognitive testing measures, as well as self-report measures. We believe that cognitive difficulties associated with cancer and chemotherapy treatments may be related to increased inflammation and other processes that can impact inflammation in the body; inflammation and inflammation-related processes are associated with cognitive difficulties in other diseases, and the same may be true for cancer and cognition.  Inflammation is the basic way in which the body reacts to infection, irritation or other injury.  We will evaluate these relationships in this study by assess the participant’s blood and DNA.