1) Study Title: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment

CSMC Protocol #: 2007-18
Other Sponsoring Protocol #: PACCT-1
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN

Description: The goal is to determine whether patients who have a tumor with an Oncotype DX Recurrence Score of 11-25 benefit from chemotherapy and to confirm that patients who have a Oncotype DX Recurrence Score of less than or equal to 10 have a low risk of recurrence with hormonal therapy alone and do not need chemotherapy to reduce their risk of recurrence.

Eligibility Criteria: Patients who have adenocarcinoma of the breast who have had surgery fewer than 84 days from the date of the trial. They must be estrogen and/or progesterone receptor positive and axillary node negative. Patients may not have had prior chemotherapy, hormonal or radiation therapy, and should otherwise be in good health.

 

2) Study Title: 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

CSMC Protocol #: 2009-21
Other Sponsoring Protocol #: NSABP B-43
Principal Investigator: Henry Tsai, MD, Sub-Investigators Edward Soffen, MD, Jeffrey Silberberg, MD, Aileen Chen, 
Study Coordinator: Jennifer Beukers, RN 732-303-5047

Description: The primary objective of this study is to determine whether trastuzumab given during radiation therapy is more beneficial for preventing recurrence of ductal carcinoma in situ (DCIS; non-invasive breast cancer) that was removed by lumpectomy or the occurrence of invasive breast cancer in the skin or breast tissue of the same breast when compared to radiation therapy alone in women with HER2-positive (a protein that is overexpressed in some women with breast cancer).

Eligibility Criteria: Patients must be female, HER2 positive, 18 years of age or older, with an ECOG performance status of 0 or 1, with ductal carcinoma in situ (DCIS), isolated tumor cells ¡Ü 0.2 mm, resected by lumpectomy, with the interval between the last surgery for excision of DCIS and randomization no more than 120 days. Patients with a prior history of breast cancer or contralateral breast cancer including DCIS, invasive breast cancer, multicentric DCIS, breast irradiation administered before randomization, other malignancies unless disease-free for 5 or more years and at low risk for recurrence, prior anthracycline chemotherapy for any malignancy, cardiac disease that would preclude the use of the drugs included, uncontrolled hypertension, or pregnant/lactating at the time of study entry are inelligible.

 

3) Study Title: A randomized study to prevent Lymphedema in women treated for breast cancer

CSMC Protocol #: 2009-17

Other Sponsoring Protocol #: CALGB 70305
Principal Investigator: Jarrod Kaufman, M.D., Jennifer Beukers, RN, Marinelle Japzon, PT, Elissa Fiorito, PT
Study Coordinator: Jennifer Beukers, RN

Description: The determine the effects of an education program on whether or not a woman gets Lymphedema and the quality of life in women treated for breast cancer.

Eligibility Criteria: Women, age 18 or older, newly diagnosed with Stage I-III cancer of the breast, with no prior history of breast cancer. Patients with other invasive cancers who have completed treatment and are 5 years post-diagnosis are eligible. Patients who have only surgery are eligible. Patients scheduled for radiation or chemotherapy must have pre-surgery measurements. Women are not eligible if they already have Lymphedema, are homebound, not able to walk independently, and are unable to participate in a mild exercise program. Women who participate in the study must be willing to complete the 18 months of the study.

1) Study Title: 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

CSMC Protocol #: 2006-15
Other Sponsoring Protocol #: CALBG/SWOG C80405
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN

Description: To determine whether cetuximab plus chemotherapy or cetuximab plus bevacizumab plus chemotherapy is better than the combination of bevacizumab with chemotherapy in treating patients with colorectal cancer.

Eligibility Criteria: Patients diagnosed with colorectal cancer who are not currently undergoing treatment.

 

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

CSMC Protocol #: 2007-09
Other Sponsoring Protocol #: ECOG E5202
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN

Description: To determine whether adding bevacizumab to a standard combination of chemotherapy drugs (5-fluorouracil (5-FU), leucovorin and oxaliplatin) is better for treating colon cancer patients who may be at increased risk for recurrence based on markers shown in their tumor. Also, to see if adding bevacizumab will help prevent the cancer from coming back.

Eligibility Criteria: Patients who have had surgery to remove a tumor that extends through the wall of the colon, but is not found in the lymph nodes or any other organs.

1) Study Title: A Phase III Randomized Trial of Adjuvant Chemotherapy with or Without Bevacizumab for Patients with Completely Resected Stage 1B (less than or equal to 4cm)-IIIA Non-Small Cell Lung Cancer (NSCLC).

CSMC Protocol #: 2007-19

Other Sponsoring Protocol #: ECOG E1505
Principal Investigator: Jeffrey Silberberg, MD
Study Coordinator: Jennifer Beukers, RN

Description: The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery to remove the lung cancer.

Eligibility Criteria: Patients who have undergone surgery no less than six weeks and no more than 12 weeks from starting the trial, and who have received no prior chemotherapy, hormonal or radiation therapy.

 

2) Study Title: A Phase III randomized trial of lobectomy versus sublobar resection for small (¡Ü2 cm) peripheral non-small cell lung cancer

CSMC Protocol #: 2009-09

Other Sponsoring Protocol #: CALGB 140503
Principal Investigator: HA Shakir, MD, Sub-PI SA Croce, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047

Description: The purpose of this clinical trial is to look at whether removal of a small section of lung (called a sublobar resection) is equal to a lobectomy (a larger surgery which takes out an entire section or ¡®lobe¡¯ of the lung, or about one-quarter to one-half of one lung, depending on which lobe is taken out) in patients who have small tumors with no evidence of spread. This clinical trial will be studying the overall effects (good and/or bad) of a sublobar resection (smaller segment of your lung) compared to a lobectomy (entire lobe of your lung).

Eligibility Criteria: Patients with non-small cell lung cancer peripheral lung nodules ¡Ü 2 cm on preoperative CT that are suitable for either lobar or sublobar resection, with an ECOG performance score of 0-2, and who are ¡Ý 18 years. Patients are not eligible if they have ground glass opacities or pathologically confirmed N1 or N2 disease; have had a malignancy within 5 years for which they have had chemotherapy or radiation therapy; or have evidence of locally advanced or metastatic disease.

CSMC Protocol #: 2007-11
Other Sponsoring Protocol #: RTOG 0232
Principal Investigator: Edward Soffen, MD
Study Coordinator: Jennifer Beukers, RN

Description: To compare the effects of two different radiation treatments in patients with prostate cancer.

Eligibility Criteria: Patients who have been diagnosed with adenocarcinoma of the prostate who have had no previous chemotherapy or radiation therapy and the cancer has not spread to other parts of the body.

 

 

2) Study Title: A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

CSMC Protocol #: 2008-09
Other Sponsoring Protocol #: RTOG 0534
Principal Investigator: Edward Soffen, MD
Study Coordinator: Jennifer Beukers, RN

Description: The purpose of this study is to compare the effects of three treatment methods: 1) Radiation therapy to the prostate bed only; 2) hormone therapy plus radiation therapy to the prostate bed; and 3) hormone therapy plus radiation therapy to the prostate bed and the pelvic lymph nodes. Patients will be randomly assigned to one of the three treatments.

Eligibility Criteria: Patients must be diagnosed with adenocarcinoma of the prostate and have had radical prostatectomy. The cancer must be localized to the prostate only and have a PSA level of more than 0.2 ng/ml and less than 2.0 ng/ml.

CSMC Protocol #: 2009-16
Other Sponsoring Protocol #: SWOG S0777

Principal Investigator: Jeffrey Silberberg, MD; Sub-Investigator Aileen Chen, MD
Study Coordinator: Jennifer Beukers, RN 732-303-5047

Description: The purpose of this study is to compare the effects, good and/or bad, of two different combinations of drugs to evaluate whether they can stop or slow down the progression of multiple myeloma, and if so, which combination of drugs is more effective. Patients will be randomly assigned to take: 1) a two-drug combination (CC-5013 [lenalidomide], an experimental drug, and low dose dexamethasone, also called "LLD"); or 2) a three-drug combination (CC-5013 [lenalidomide], low dose dexamethasone, and an experimental drug called bortezomib ([Velcade®], also called "BLLD").

Eligibility Criteria: Patients are eligible who are ≥ 18 years of age, with newly diagnosed multiple myeloma (MM), with measurable disease, with non-secretory MM if the baseline serum Freelite is elevated, with Zubrod PS of 0-3, who are able to take ASA 325mg daily (or enoxaparin 40 mg SQ daily) as prophylactic anticoagulation. Patients who are pregnant, have received prior chemotherapy for this disease, have received prior radiation treatment to more than half of the pelvis, or had any prior treatment with bortezomib or lenalidomide are not eligible.

1) Study Title: Tysabri® Global Observational Program in Safety (TYGRIS)

 

CSMC Protocol #: 2008 01

Other Sponsoring Protocol #: Biogen Idec TYGRIS 101-MS-402

Principal Investigator: Amos Katz, M.D.

Study Coordinator: Michele Emmons, RN

 

Description: The purpose is to collect information on serious infections, cancers and other side effects that may occur with patients treated with Tysabri®

 

Eligibility Criteria: Patients enrolled in the TOUCH Prescribing Program who are being treated with Tysabri®.