Status:
COMPLETED
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Drugs used against cancer 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 t...
Eligibility Criteria
Inclusion
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- Inoperable metastatic disease
- Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue
- Presence of at least 1 bi-dimensionally measurable index lesion
Exclusion
- Previous irinotecan-based chemotherapy
- Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
- Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment
- Brain metastasis
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1221 Patients enrolled
Trial Details
Trial ID
NCT00154102
Start Date
May 1 2004
End Date
March 1 2011
Last Update
January 30 2017
Active Locations (154)
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1
Research Site
Buenos Aires, Argentina
2
Research Site
Bedford Park, Australia
3
Research Site
Darlinghurst, Australia
4
Research Site
Heidelberg, Australia