Table of Contents
(Irinotecan, CPT-11)
Presentation Agenda
CPT-11 Presentation Team
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Colorectal Cancer in 2000
5-FU Therapy: With and Without LV
5-FU Therapy: Infusional vs Bolus
CPT-11 Therapy of Colorectal Cancer
First-Line, Single-Agent CPT-11 Therapy
Second-Line CPT-11 Therapy (V301)
Second-Line Survival (V301)
Second-Line CPT-11 Therapy (V302)
Second-Line Survival (V302)
Rationale for First-Line CPT-11 Combination Therapy
Phase I Combination Dose-Finding and Pharmacokinetic Studies
Pivotal Phase III Trials
Pivotal First-Line Trials
Entry Criteria (0038)
Entry Criteria (V303)
Treatment (0038)
Treatment (V303)
Endpoints (0038)
Endpoints (V303)
Patient Evaluation (0038)
Patient Evaluation (V303)
Sample Size Calculation (0038)
Sample Size Calculation (V303)
Treatment Arms (0038)
Treatment Arms (V303)
Study Enrollment and Follow-Up (0038)
Study Enrollment and Follow-Up (V303)
Pivotal Phase III Trial Results
Patient Enrollment (0038)
Patient Enrollment (V303)
Demographics (0038)
Demographics (V303)
Disease Characteristics (0038)
Disease Characteristics (V303)
Disease History (0038)
Disease History (V303)
Baseline Laboratory Abnormalities (0038)
Baseline Laboratory Abnormalities (V303)
Treatment Administration (0038)
Treatment Administration (V303)
Pivotal Phase III Trial Results
Confirmed Response Rates (0038,V303)
Time to Tumor Progression (0038,V303)
Time to Tumor Progression (0038)
Time to Tumor Progression (V303)
Cox Regression Analysis: TTP (0038)
Cox Regression Analysis: TTP (V303)
Survival (0038,V303)
Survival (0038)
Survival (V303)
Cox Regression Analysis: Survival (0038)
Cox Regression Analysis: Survival (V303)
Post-Study Therapy (0038)
Post-Study Therapy (V303)
Adverse Events (0038)
Adverse Events (V303)
Pivotal Phase III Trial Results
EORTC QLQ-C30 Quality of Life (0038)
EORTC QLQ-C30 Quality of Life (0038)
EORTC QLQ-C30 Quality of Life (0038)
EORTC QLQ-C30 Quality of Life (V303)
Summary and Conclusions
Efficacy Summary
Safety Summary
Quality of Life Summary
Conclusion
Proposed New Indication
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