UCSF Helen Diller Family Comprehensive Cancer Center
Protocol Summary

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Protocol No.CALGB-80702Principal InvestigatorVenook, Alan
PhaseIII (Cancer Control)
Age GroupAdultScopeNational
Secondary Protocol No.CALGB 80702
TitleA Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
Objective--To compare the disease-free survival of patients with Stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily
Key Eligibility* Histologically confirmed adenocarcinoma of the colon - Stage III disease - Gross inferior (caudal) margin of the primary tumor must be >/= 12 cm from the anal verge -- No rectal cancer - Synchronous colon cancers allowed -- No synchronous colon and rectal primary tumors * Completely resected tumor - Patients with adherent to adjacent structures, en bloc R_o resected tumor, must have it documented in the operative report * At least 1 pathologically confirmed positive lymph node OR the AJCC v. 7 designation of N1C defined as tumor deposit(s) in the subserosa, mesentery, nonperitonealized pericolic, or perirectal tissues without regional lymph node metastases * No evidence of residual involved lymph node disease or metastatic disease
Applicable Disease SitesColon
Therapies InvolvedChemotherapy multiple agents systemic
Drugs Involved5-Fu (Fluorouracil)
Celebrex (Celecoxib)
Celecoxib
Eloxatin (Oxaliplatin)
Leucovorin
Oxaliplatin
Placebo
StatusOpen
Participating InstitutionsMt. Zion : Sharvina Ziyeh
Eligibility DocumentCALGB-80702_CTGov_Eligibility_NCT01150045.doc
Other Attachments80702_Lay Summary.pdf
ContactSharvina Ziyeh Phone:415-353-7683
Pager:
Email:ZiyehS@cc.ucsf.edu