Cetuximab and Best Supportive Care Compared with Best Supportive Care Alone in Treating Patients with Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.

Phase 3

Completed

• Conditions: Colorectal Cancer- stage IV colon cancer- recurrent colon cancer- recurrent rectal cancer- stage IV rectal cancer; Colorectal Cancer; - stage IV colon cancer; - recurrent colon cancer; - recurrent rectal cancer; - stage IV rectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12606000112561
• Lead Sponsor: ational Cancer Institute of Canada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Histologically confirmed colorectal cancer- Metastatic disease- Epidermal growth factor receptor (EGFR)-positive by immunochemistry- Measurable or evaluable disease- Not amenable to standard curative therapy- Best supportive care is the only available option- Must have received a prior thymidylate synthase inhibitor (eg: fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting- Combination therapy with oxaliplatin or irinotecan allowed- Must have failed* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens.

Exclusion Criteria

No symptomatic CNS metastases.- Any condition that does not permit compliance with the protocol*NOTE: Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified