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Status:

COMPLETED

Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

Australasian Gastro-Intestinal Trials Group

Conditions:

Colorectal Cancer

Quality of Life

Eligibility:

All Genders

16-120 years

Phase:

PHASE3

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the u...

Detailed Description

OBJECTIVES: Primary * Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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 (e.g., 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
  • No symptomatic CNS metastases NOTE: \*Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen
  • PATIENT CHARACTERISTICS:
  • Age
  • 16 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 75,000/mm\^3
  • Hemoglobin ≥ 8.0 g/dL
  • Hepatic
  • AST and ALT ≤ 5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No uncontrolled angina
  • No arrhythmias
  • No cardiomyopathy
  • No congestive heart failure
  • No myocardial infarction\* within the past 6 months NOTE: \*Pre-treatment ECG as only evidence of infarction is allowed
  • Pulmonary
  • No severe restrictive lung disease
  • No interstitial lung disease by chest x-ray
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment
  • No active pathological condition that would preclude study participation
  • No psychological or geographical condition that would preclude study compliance
  • No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior cetuximab
  • No prior murine monoclonal antibody therapy (e.g., edrecolomab)
  • Chemotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy
  • Radiotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Concurrent palliative radiotherapy allowed except to index lesions
  • Surgery
  • At least 4 weeks since prior major surgery and recovered
  • Other
  • No prior EGFR-targeted therapy (e.g., erlotinib or gefitinib)
  • More than 30 days since prior experimental therapeutic agents
  • More than 4 weeks since prior investigational agents
  • No concurrent enrollment in another clinical study
  • No other concurrent EGFR-targeted therapy
  • No other concurrent non-cytotoxic experimental agents

Exclusion

    Key Trial Info

    Start Date :

    December 30 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 10 2009

    Estimated Enrollment :

    572 Patients enrolled

    Trial Details

    Trial ID

    NCT00079066

    Start Date

    December 30 2003

    End Date

    February 10 2009

    Last Update

    August 4 2023

    Active Locations (33)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 9 (33 locations)

    1

    NHMRC Clinical Trials Centre

    Camperdown, New South Wales, Australia, 1450

    2

    Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, Canada, T6G 1Z2

    3

    British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, Canada, V1Y 5L3

    4

    Fraser Valley Cancer Centre at British Columbia Cancer Agency

    Surrey, British Columbia, Canada, V3V 1Z2