(Irinotecan, CPT-11)

4/13/00


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Table of Contents

(Irinotecan, CPT-11)

Presentation Agenda

CPT-11 Presentation Team

PPT Slide

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

PPT Slide

Author: LLMiller