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Partial List of Available Studies

Below is a listing of some of the studies currently available through Oncology Care Consultants and the FMH Regional Cancer Therapy Center. We add new studies frequently. Please contact the study coordinator if you have any questions.

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Breast Cancer Studies
Colon Cancer Studies
Kidney Cancer Studies
Lung Cancer Studies

Breast Cancer, adjuvant therapy

N063D: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study:  A Randomized, Multi-center, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, their Sequence and their Combination in Patients with Her2/Erbb2 Positive Primary Breast Cancer (The ALTTO study).
Previous research has proven that Trastuzumab-based treatment for patients with Her2 positive breast cancer is extremely beneficial.  The ALTTO study compares Trastuzumab to a newer and potentially even more effective oral drug, Lapatinib, The study also offers a combination of the two drugs, or the drugs may be given sequentially.

PACCT-1: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial.
 This research study is for patients with early-stage breast cancer sorted by a new test, known as Oncotype DX. The Oncotype test reports a “recurrence score” which provides genetic information about a patient’s tumor and which  predicts the likelihood of cancer returning within 10 years of initial diagnosis. Oncotype DX has been approved by the FDA. Knowing a patient’s recurrence score can be of great help in deciding whether patients with early stage breast cancer actually need to receive chemotherapy, or if less aggressive anti-hormonal treatments will be equally effective.
                
IBCSG 25-02: TEXT study evaluating the role of exemestatane plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer
Breast cancer in pre-menopausal women can be a particularly aggressive disease. In the TEXT study, patients receive ovarian suppression in the form of  monthly injections or surgery. Patients also take a pill daily (either tamoxifen or exemestane) as well as standard treatment for their disease (surgery, radiation, chemotherapy as appropriate).

ECOG E5103:  A 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 
This study offers women one of the most effective  currently-known treatment regimen  plus a newer, and potentially even more effective treatment option, bevacizumab. Bevacizumab is a biological therapy that targets blood vessel formation within tumors.

NSABP B-46: A clinical trial comparing the combination of Taxotere and cytroxan plus bevacizumab and Taxotere and Cytoxan alone and Adriamycin, Taxoere and Cytoxan for node positive and high risk node negative HER-2 negative breast cancer.

Breast Cancer, Advanced

CALGB 40502: A randomized Phase III trial of weekly Paclitaxel (Taxol) compared to Nanoparticle Albumin Bound Nab-Paclitaxel (Abraxane) or Ixabepilone (Ixempra) combined with Bevacizumab for locally recurrent or metastatic breast cancer. 

Breast Cancer, Advanced and Hormone Receptor Positive

BOLERO: A research study combining the Aromatase inhibitor, Exemestane, with Everolimus for post menopausal women with hormone receptor positive breast cancer that has progressed while on another hormonal therapy.

Colon Cancer, Adjuvant Therapy

E5202: A Randomized Phase III Study Comparing 5 FU, Leucovorin and Oxaliplatin versus 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. It is not known if patients with an early stage of colon cancer (stage II) need to receive chemotherapy following removal of the tumor.  This study examines molecular markers found within the tumor cells in order to choose those patients who are most likely to benefit from chemotherapy. Patients on this study are given standard chemotherapy with or without a targeted therapy (Bevacizumab). Patients whose tumor cells do not show the molecular markers are placed into close observation without treatment. 

Colorectal Polyp Prevention Trial

P-5 - "Statin Polyp Prevention Trial in Patients with Resected Colon Cancer" This research study is designed to determine the effect of rosuvastatin (the cholesterol-lowering drug, Crestor), taken postoperatively for five years, on the occurrence of pre-cancerous polyps of the colon and rectum or the recurrence of cancers of the colon and rectum.

Colon Cancer, Advanced

CALGB 80405: A Phase III trial of Irinotecan/5FU/Leucovorin or oxaliplatin/5-FU/Leucovorin with Bevacizumab or Cetuximab or with both of these drugs for patients with metastatic colon or rectal cancer that is previously untreated. This study compares two of the most common treatment protocols for metastatic colon carcinoma with two new forms of immunotherapy (antibodies against blood vessel growth factors) for patients whose cancer has reoccurred or spread.

Kidney Cancer, Adjuvant Therapy

2805: “A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib vs. Sorafenib vs. Placebo in Patients with Resected Renal Cell Carcinoma”.                       
At present, there is no proven drug that can prevent the recurrence of kidney cancer after surgery.  In this study, patients with high risk disease following surgical removal of their tumor receive one of two oral targeted drugs (Sorafenib or Sunitinib) or a placebo.

Kidney Cancer, Advanced

E2804 The BeST Trial:  A Randomized Phase II Study of VEGF, RAF kinase, and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma
This study treats patients with advanced kidney cancer with a unique combination of oral and intravenous targeted medications (not standard chemotherapy) in an attempt to improve the response rate and decrease toxicity of the treatments.

 

Lung Cancer, Adjuvant Therapy

ECOG E1505:  A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with completely resected Stage IB to IIIA non-small cell lung cancer
This study treats patients whose lung cancer that has been surgically removed.  It evaluates the benefit of standard chemotherapy along with a targeted therapy (bevacizumab).  The aim of the study is to determine whether bevacizumab plus chemotherapy is a better treatment option than chemotherapy alone.

Lung Cancer, Advanced

H2E-MC-JMHD: A randomized open label study of Pemetrexed plus carboplatin and bevacizumab followed by maintenance Pemetrexed and bevacizumab versus Paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with Stage IIIB or IV non-small lung cancer (NSCLC).  Lung cancer is the most common cancer and the leading cause of cancer deaths in the U.S. Studies have shown that Pemetrexed is effective in the initial treatment of NSCLC (induction treatment), but most patients almost always progress at some point after treatment.  In this research study, we are attempting to prolong remissions with additional treatments. Patients with advanced non-squamous NSCLC will receive four cycles of induction chemotherapy, followed by maintenance therapy until disease progression. 

This is a partial listing of the clinical research studies available through the physicians of Oncology Care Consultants. If you would like to receive more information about these or other studies please e-mail us at clinicaltrials@fmh.org.

 

                   

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