Clinical Trial: Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Ca

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetuximab followed by additional radiotherapy in patients with locally advanced anal cancer.

Secondary

  • Evaluate colostomy-free survival.
  • Evaluate the local control rate (objective response and stabilization) at 8 weeks.
  • Evaluate relapse-free survival at 5 years.
  • Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
  • Evaluate overall survival at 5 years.
  • Evaluate the duration of response.
  • Evaluate acute toxicities according to CTCAE v3.0.
  • Evaluate late toxicities at 5 years according to CTCAE v3.0.
  • Study the tumor markers associated with response (survival without relapse) and toxicity.
  • Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their association with skin toxicity, objective survival, and relapse-free survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10 and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two we
Sponsor: UNICANCER

Current Primary Outcome: Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival rate at 3 and 5 years
  • Colostomy-free survival at 3 and 5 years
  • Duration of objective response


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 7, 2009
Date Started: March 2009
Date Completion:
Last Updated: July 8, 2011
Last Verified: July 2011