Payson Center for Cancer Care Clinical Trials

CALGB 40603: Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose Dense AC in Hormone Receptor Poor / HER 2 Negative Resectable Breast Cancer

• Women who have triple negative breast cancer may be eligible for this trial. The study will evaluate whether adding other drugs to standard neoadjuvant chemotherapy can help shrink triple-negative breast cancer faster and lower the risk of the cancer coming back in other parts of the body.

CALGB 40601: Randomized Phase III Trial of Paclitaxel Combined with Transtuzumab, Lapatinib, or Both as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer)

• Patients who have operable stage II-III invasive breast cancer that is HER2 positive may be eligible for this study. Patients will be randomized to one of three groups to compare tumor shrinkage prior to surgery: paclitaxel and trastuzumab given by vein and lapatinib taken by mouth; or paclitaxel and trastuzmab by vein; or paclitaxel and lapatinib taken by mouth. All three groups will have surgery to remove any remaining breast cancer.

CALGB 40502: Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixabepilone Combined with Bevacizumab as First-line Therapy for Locally Recurrent or Metastatic Breast Cancer

• Patients who have locally recurrent or metastatic breast cancer and have not had chemotherapy treatment for the disease may be eligible for this study. Patients will be randomized to one of three groups using different chemotherapy agents in combination with bevacizumab.

CTSU N063D: ALTTO-adjuvant Lapatinib and/or Transtuzumab Treatment Optimization Study: Randomized, Multi-Centre, Open Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, their Sequence and their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer

• Patients who have HER2+ early breast cancer may be eligible for this study. All patients will receive paclitaxel and then would be enrolled into one of four groups to receive: standard treatment – trastuzumab; lapatinib; trastuzumab and then lapatinib; or trastuzmab and lapatinib together for up to 1 year. Paclitaxel and trastuzmab are given in the vein and lapatinib is a pill.

CTSU ECOG E5103: Double-blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer.

• Patients with lymph node positive and high risk lymph node negative breast cancer may be eligible for this study. Patients would be randomized to one of three groups. The main purpose of the study is to determine whether adding bevacizumab with the current standard chemotherapy medications reduces the risk of recurrence.

CALGB 40302: Endocrine Therapy with or without Inhibition of EGF and HER2 Growth Factor Receptors: Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatinib (GW572016) for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer

• Post-menopausal women with advanced breast cancer may be eligible for this study to see if adding a new anti-cancer drug, lapatinib, can add to the benefits of the standard anti-estrogen drug fulvestrant. Patients who enroll would receive either a fulvestrant injection and a lapatinib tablet or fulvestrant injection and a placebo tablet (a tablet that looks like the investigational agent but doesn’t have any medication in it) for 28 days.

NSABP B42 Clinical Trial to Determine the Efficacy of 5 years of Letrozole Compared to Placebo in Patients Completing 5 years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer

• Women who have had 5 years of hormone therapy for breast cancer are eligible to enroll in this study which will investigate whether an additional 5 years of hormone therapy with letrozole may further reduce the chance of breast cancer returning.

Program for the Assessment of Clinical Cancer Tests (PACCT) Trial Assigning IndividuaLized Options for Treatment (TAILORx)

• Women with localized breast cancer will have a diagnostic test that indicates the possible risk of disease recurrence. Based on their test results, women will be assigned to one of three study groups in which they will receive hormone therapy, chemotherapy, or both.

S0307: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

• Women with stage I, II, or III breast cancer currently in remission are eligible to participate in this study to investigate whether adding a bone-strengthening drug to hormone therapy or to chemotherapy may help to prevent cancer from spreading to the bones or to other parts of the body.

CTSU S0226:Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast cancer

• Postmenopausal women with breast cancer that has spread will be randomly assigned to receive either one hormonal agent or a combination of two hormonal agents.

RTOG 0413: Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with stage 0, I, or II Breast Cancer

• Women who have a lumpectomy as surgery for breast cancer will be randomly assigned to receive whole breast irradiation or partial breast irradiation.

CALGB 40101: Cyclophosphamide and Doxorubicin (CA 4 vs 6 cycles) Versus Paclitaxel (4 vs 6 cycles) as Adjuvant Therapy for Women with Node-negative Breast Cancer: A 2x2 Factorial Phase III Randomized Study

• Women with localized breast cancer who have not previously received chemotherapy and have had surgical resection will be randomly assigned to one of two different chemotherapy drug treatments.

CALGB 369901: Observational Cohort Study Chemotherapy Decisions and Outcomes in Women Age 65 or Older with Operable, Newly Diagnosed Breast Cancer

• Women aged 65 or older who have recently had a positive biopsy or surgery for breast cancer may participate in this survey. The survey looks at how and why women make the decision to undergo or not to undergo chemotherapy as part of their treatment.

CTSU IBCSG 24-02(SOFT) Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer

• Premenopausal women who have had surgery for breast cancer will be randomized to one of three treatments: A drug which blocks the activity of estrogen
  OR
  A drug which blocks the activity of estrogen, with one of three options to prevent the ovaries from producing estrogen
  OR
  A drug that interferes with the body’s production of estrogen, together with one of three options to prevent the ovaries from producing estrogen.

HIC 10-1 CTSU WFU 91105: Phase III Double Blind, Placebo Controlled Study of Donepezil in Irradiated Brain Tumor Patients

• Patients who have received radiation therapy for a brain tumor may be eligible for this study. The purpose of this study is to see if the study drug, donepezil (Aricept), will improve memory loss, confusion and slow thinking that have occurred after getting radiation treatments for a brain tumor. The study will also look at whether donepezil improves mood and quality of life.

RTOG 0614: Randomized, Phase III, Double-blind, Placebo-controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-brain Radiotherapy

• Patients who are scheduled to receive whole-brain radiation may be eligible for this study. Patients will be randomized to receive either memantine(a pill) or placebo for a total of 24 weeks to see if memantine is effective in preventing memory problems for patients receiving whole-brain radiation.

HIC 10-5 CALGB 80502: (A Phase II Trial of Irinotecan and AZD2171 in Patients with Metastatic Colorectal Cancer after Progression on First-line Oxaliplatin, Fluoropyrimidine, and Bevacizumab)

• Patients with metastatic colorectal cancer (colon or rectal cancer that has spread to other parts of the body) that has gotten worse after treatment may be eligible for this study. The purpose of this study is to test an experimental drug call AZD2171 to see if it provides any benefit in this type of cancer. AZD2171 works by interfering with abnormal blood vessel formation in tumors similar to the way bevacizumab (Avastin) works.

CTSU NSABP R-04: Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum

• Patients who have operable cancer of the rectum may be eligible for this study. In this study, chemotherapy and radiation therapy will be given before surgery. Most doctors do surgery first and then give the chemotherapy and radiation. The study will also compare four different chemotherapy treatments so patients will be randomized to receive one of the four treatments. Oxaliplatin and 5-FU are given intravenously and capecitabine is a pill given by mouth.

N0147: Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

• Patients with stage III colon cancer who have undergone surgery are eligible to be randomly assigned to receive either a set of standard chemotherapy drugs or standard drugs plus an investigational drug.

ECOG 5202: Randomized Phase III Study Comparing 5-FU, Leucovorin, and Oxaliplatin to the Same chemotherapy with Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence, to Determine Prospectively the Prognostic Value of Molecular Markers

• Patients with locally advanced colon cancer will have a test that shows that the individual may be a high risk for tumor recurrence. Patients who may be at high risk will receive standard chemotherapy with or without an additional investigational drug. Patient who may be at low risk for recurrence will be monitored carefully but will not need chemotherapy at this time.

CALGB/SWOG 80405: Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

• Patients with cancer of the colon or rectum which has spread and has not yet been treated will be randomly assigned to receive one of two standardized chemotherapy treatments with an additional approved drug
  OR one of two standardized chemotherapy treatments with an experimental drug
  OR one of two standardized chemotherapy treatments with both of these two additional drugs.

RTOG 0436: Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin and Radiation for Patients with Esophageal Cancer who are Treated without Surgery

• Patients who have esophageal cancer and have not had surgery may be eligible for this study. Patients will be randomized into one of two groups, to receive radiation treatment and chemotherapy or radiation treatment, chemotherapy and cetuximab.

CALGB 80302: Phase II Trial of Preoperative Irinotecan, Cisplatin, and Radiation in Esophageal Cancer

• Individuals diagnosed with localized esophageal cancer are eligible for this study. Participants will receive chemotherapy and radiation therapy before surgery, rather than surgery alone or chemotherapy and radiation without surgery.

HIC 10-6 CALGB 30506: (A Randomized Phase III Trial of Adjuvant Therapy in Early Stage Non-small Cell Lung Cancer Evaluating the Potential Utility of a Genomic Prognostic Model to Identify Patients as Candidates for Adjuvant Chemotherapy)

• Patients with early stage Non-Small Cell Lung cancer and will undergo surgery to remove the tumor may be eligible for this study. The purpose of this trial is to study a new laboratory test called the Lung Metagene Score (LMS) to see if the results of the test can indicate whether or not a tumor will recur. Standard therapy is to do surgery alone without chemotherapy, however some patients have their cancer reoccur. Patient’s will have their tumor tissue used for the LMS. If the test confirms eligibility, patients will be randomized to receive either observation or chemotherapy.

HIC 10-4 CALGB 30801: (A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced NSCLC)

• Patients with Advanced Non-Small Cell Lung cancer whose tumor’s have high levels of COX-2 may be eligible for this study. The purpose of the study is to see if adding celecoxib versus placebo to standard chemotherapy has any benefit.

CALGB 30607: Randomized Phase III, Double-blind Placebo Controlled Trial of Sunitinib as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-based Combination Chemotherapy in Advanced Stage IIIB/IV NSCLC)

• Patients with advanced stage IIIB/IV non-small cell lung cancer may be eligible for this study. Patients will be randomized to receive either Sunitinib or placebo after standard chemotherapy to see if Sunitinib helps their tumor shrink or stops growing.

RTOG 0617: Randomized Phase III Comparison of Standard Dose (60 Gy) Versus High Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel + / - Cetuximab in Opatients with Stage IIIA/IIIB Non-small Cell Lung Cancer

• Patients with stage IIIA/IIIB non-small cell lung cancer who are not eligible for surgical removal (inoperable) may be eligible for this study. Patients will be randomized into one of four groups. The study will compare high dose radiation therapy and standard dose radiation as well as comparing the addition of cetuximab.

CALGB 30610: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide

• Patient who have limited small cell lung cancer may be eligible for this trial. The study will evaluate the effects of three different ways to give radiation therapy. One of the treatments is standard the other two of the treatments are experimental. Patients will be randomized to receive one of the three treatments. The chemotherapy received in the study is standard treatment.

CALGB 30605: Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-risk Stage III Non-small Cell Lung Cancer (NSCLC)

• Patients eligible who have stage III NSCLC that cannot be removed by surgery will receive induction chemotherapy with albumin-bound paclitaxel and carboplatin in their vein then will received concurrent radiotherapy and erlotinib, which is a pill, for up to 16 weeks.

CALGB 30504: Phase IB/II Study of the Combination Cisplatin, Etoposide and Sunitinib for Untreated Extensive Stage Small Cell Lung Cancer

• Cisplatin and etoposide are currently approved for use in patients with extensive small cell lung cancer. This study adds the medication, sunitinib. Sunitinib is an oral medication that inhibits vascular endothelial growth factor. Vascular endothelial growth factor levels are elevated in many of these malignancies. In this study, a small number of patients will participate first to determine the best dose of sunitinib combined with cisplatin and etoposide. Then a larger group of patients will receive that dose and be followed for a period of time.

S0424: Molecular Epidemiology Case-series Study of Non-small Cell Lung Cancer in Smoking and Non-smoking Women and Men

• Men and women who are newly diagnosed with non-small cell lung cancer are eligible for this study. The researchers will assess tissue samples for specific tobacco smoke carcinogens in both smokers and non-smokers.

CALGB 79803: Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-small-cell Lung Cancer

• Patients who have had surgical resection for non-small cell lung cancer and who have not received chemotherapy or radiation for their disease will be randomly assigned to receive either selenium (a trace mineral) or a placebo (a pill that contains no medicine).

CALGB 10404: Randomized Phase II Study of Three Fludarabine/antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia

• Patients who have been diagnosed with chronic lymphocytic leukemia (CLL) and have not had prior treatment may be eligible for this study. Patients would be randomized into one of three groups.

CALGB 9665: CALGB Leukemia Tissue Bank (A Companion Study for CALGB 10404)

• This is a companion tissue bank for patients enrolled in the CLL trial. It would allow researchers to use samples for additional studies to help evaluate better treatments.

CALGB 50401: Randomized Phase II Trial of Rituximab vs. Lenalidomide (revlimid) vs. Rituximab + Lenalidomide in Recurrent Follicular Non-hodgkin Lymphoma (NHL) that is not Rituximab-refractory

• Patients eligible for this trial would be randomly assigned to receive either lenalidomide or lenalidomide and rituximab. The investigational drug lenalidomide is given orally.

CTSU WFU-97405: Randomized Study of Soy Protein and Effexor XR™ on Vasomotor Symptoms of Men with Prostate Cancer

• Men undergoing hormonal manipulation for treatment or control of prostate cancer often suffer hot flashes. This study will evaluate whether Soy Protein and Effexor XR™ (a medication used to treat depression) are helpful in reducing the number and/or severity of these symptoms.

RTOG 0415: A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-risk Prostate Cancer

• Patients who have prostate cancer may be eligible for this study. This study will compare three-dimensional therapy or intensity modulated radiation therapy (IMRT) in the standard dose of 41 treatments over 8 weeks versus a high daily dose (which is experimental) of 28 treatments over 5 and a half weeks to see if the effects of the treatments are similar.

CALGB 90202: Randomized, Double-blind, Placebo-controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

• Patients who have metastatic to the bone prostate cancer may be eligible for this study. This study will compare the effects of early treatment with zoledronic acid (zometa) compared to standard treatment with zoledronic acid (zometa). Zoledronic acid is an intravenous infusion.

CTSU S0421: Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer

• Patients eligible for this trial would be randomly assigned to receive either docetaxel, prednisone and the investigational drug atrasentan or docetaxel, prednisone and a placebo. The investigational drug atrasentan is given orally.

CALGB 90203: 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

• Men who have prostate cancer and are at risk of the cancer returning after surgery to remove their prostate are eligible for this study. The study will compare the effects of hormone therapy and chemotherapy before surgery compared to just surgery alone.

RTOG 0631: Phase II/III Study of Image Guided Radiosurgery / SBRT for Localized Spine Metastasis

• Multiple radiation treatments are frequently used to treat pain caused by cancer that has spread to the spine. Image guided radiosurgery/ stereotactic body radiation (SBRT) is a treatment that uses highly focused x-rays to deliver a single high dose on a specific area of the body. This study will evaluate the effect of SBRT on the cancer that has spread to the patient’s spine and also has a second phase to evaluate the effects of SBRT to Standard radiation therapy to find out which treatment provides the most rapid pain relief with the least side effects.

RTOG 0825: Phase III Double-blind Placebo-controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoraditation and Adjuvant Temozolmide in Patients with Newly Diagnosed Glioblastoma

• Patient with newly diagnosed glioblastoma may be eligible for this study. The study will evaluate the addition of bevacizumab given through a vein in improving overall outcomes of patients with this disease. Patients will be randomized to receive bevacizumab or placebo to the standard care.

CALGB 70604: Randomized Phase III Study of Standard Dosing vs. Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer)

• Patients with breast cancer, prostate cancer, or multiple myeloma may be eligible for this study. Patient will be randomized to receive standard dosing interval with Zoledronic acid through their vein or longer dosing interval of Zoledronic acid to compare efficacy and safety.

CALGB 17061: A phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated with Chemotherapy Induced Peripheral Neuropathy (CIPN)

• Patients who have peripheral neuropathy (an uncomfortable sensation that occurs mainly in the hands and feet) as a result of their chemotherapy treatment may be eligible for this study. Cymbalta (Duloxetine) is a FDA approved anti-depressant medication (pill) that is also approved for use to treat diabetic neuropathy. As these conditions are similar, it is being evaluated for its effectiveness in treating chemotherapy induced neuropathy.

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