Clinical Trials – Gastrointestinal (Esophagus, Stomatch / Gastric, Pancreatic, Rectal, Anal, Hepatic Cancers)

Clinical Trials – Gastrointestinal (Esophagus, Stomatch / Gastric, Pancreatic, Rectal, Anal, Hepatic Cancers)

Clinical Trials – Gastrointestinal (Esophagus, Stomatch / Gastric, Pancreatic, Rectal, Anal, Hepatic Cancers)

GI PROTOCOLS: Colo-Rectal
1. CALGB 80405
Locally Advanced (unresectable) or Metastatic Disease
Eligibility: Must have wild type K-ras gene as determined by central lab. No prior treatment for advanced dz; no prior Bevacizumab or Cetuximab; no history of significant bleeding ; no pleural effusion or grade 2 dyspnea; no CNS metastases; no periperal neuropathy =/> grade 2: RX: FOLFOX or FOLFIRI (physician’s choice) + Bevacizumab versus FOLFOX or FORFIRI + Cetuximab versus FOLFOX or FOLFIRI + Bevacizumab and Cetuximab. (CETUXIMAB SUPPLIED)

2. CALGB 80702
Stage III Completely Resected Adenocarcinoma of the Colon
Eligibility: en bloc resection for tumors adherent to adjacent structures; at least 1 pos node; no evidence of residual nodal dz; rectal cancer not eligible; synchronous tumors okay; NSAIDs not allowed nor aspirin exceeding 325 mg 3 x per week on average; must begin Rx 21 – 56 days post-op: Rx: FOLFOX x 12 cycles + Celecoxib/placebo versus FOLFOX x 6 cycles + Celecoxib/placebo (CELECOXIB/PLACEBO SUPPLIED)

3. NSABP P-5
Polyp prevention in Pts with Resected Colon Cancer
Eligibility: completely resected stg I or II adenoca of the colon; must enroll within 1 year of surgery; performance status 0 or 1; hyperlipidemia with indication for statin therapy not allowed; no familial adenomatous polyposis, malabsorption syndrome, ulcerative colitis or inflammatory bowel disease: Rx: Rosuvastatin 10 mg po qd x 5 yrs VS placebo. (DRUG SUPPLIED)

GI PROTOCOLS – Radiation (RTOG)
1. RTOG 1010
HER2-Positive Esophageal Adenocarcinoma
Eligibility: Primary adenocarcinoma of esophagus involves the mid (up to 25 cm), distal, or esophagogastric junction (may involve the stomach up to 5 cm); Tissue must be submitted and be HER2 positive by centralized testing; stage T1N1-2, T2-3N0-2; Performance status 0-2; No prior chemo or RT for this cancer. Rx: Trastuzumab + Taxol + Carboplatin w/RT > surgery > Trastuzumab versus Taxol + Carboplatin w/RT > surgery. (TRASTUZUMAB SUPPLIED)

2. RTOG 0848
Resected Head of Pancreas Adenocarcinoma
Eligibility: Complete excision of primary tumor (head of pancreas); stage T1-3, N0-1, M-0 interval between surgery and 1st step reg between 21-56 days; no prior chemo or RT for this cancer; Performance status 0,1. Rx: (1st randomization): Gemcitabine versus Gemcitabine + Erlotinib. If no progression (2nd randomization): 1 cycle chemo versus 1 cycle chemo > RT with Capecitabine or 5-FU. (ERLOTINIB SUPPLIED)

Abbreviations:
CALGB = Cancer and Leukemia Group B
CTSU = Cancer Trials Support Unit
ECOG = Eastern Cooperative Oncology Group
NCI = National Cancer Institute
NSABP = National Surgical Adjunct Breast and Bowel Project
RTOG = Radiation Therapy Oncology Group
SCUSF = SunCoast CCOP Research Base
SWOG = Southwest Oncology Group
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