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CPT-11 in Advanced Gallbladder or Bile Duct Tumors
NCT00003276Phase 2
Key facts
- Status
- Completed
- Start
- Mar 1998
- Primary completion
- Mar 2001
- Countries
- 2
- Sponsor
- Cancer and Leukemia Group B
- Modality
- Small Molecules
- Drugs
- irinotecan
- Conditions
- gallbladder cancercholangiocarcinoma (CCA)
01
Overview
Phase 2, open-label, single-arm trial of irinotecan in gallbladder cancer and cholangiocarcinoma (CCA), sponsored by Cancer and Leukemia Group B. Primary endpoint: Objective Tumor Response Rate at 5 years. Started Mar 1998; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
irinotecan
Patients receive irinotecan 125 mg/m2 (later reduced to 100 mg/m2) weekly for 4 weeks every 6 weeks.
03
Who it enrols
Patients with histologically proven unresectable metastatic or recurrent gallbladder or bile duct carcinoma, no prior chemotherapy for advanced disease, and adequate organ function.
04
Endpoints
Primary
Objective Tumor Response Rate
Secondary
Overall Survival
Time to Progression
Toxic Effects
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