Trial Information

Phase II Randomized Trial of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer

Rationale: Previous studies suggest that both irinotecan and Mytomycin C when administered
alone have some efficacy against stomach cancer. Based on laboratory testing, researchers
hypothesized that Mytomycin C may enhance the efficacy of irinotecan through an enzyme
called Topoisomerase I. In addition, because Mytomycin C has severe side effects, combining
these chemotherapy agents together may allow for lower dosages resulting in greater efficacy
and reduced side effects. A recent study indicates that the combination of these drugs has
promising anti-tumor activity against esophageal and stomach cancers. The current study
builds on previous research to explore the most effective schedule for administering these
drugs together.

Purpose: This study is evaluating the combination of irinotecan and Mytomycin C on two
different treatment schedules in patients with advanced esophageal and stomach cancers.
Characteristics of different genes will also be measured, along with genetic and molecular
changes by comparing test results from the beginning and end of the study.

Treatment: Patients in this study will receive irinotecan and Mytomycin C in one of two
treatment schedules. Both drugs will be administered in patients through an intravenous
infusion. A computer will randomly assign patients to a treatment group. Group one will
receive Mytomycin C on day 1 and irinotecan on days 2 and 9. Group two will receive
Mytomycin C on days 1 and 8 and irinotecan on days 2 and 9. After day 9, patients in both
groups will not be given any study drugs for almost three weeks to complete a four week
cycle. Several tests and exams will be given throughout the study to closely monitor
patients. Patients will continue receiving the study drugs until they experience disease
growth or unacceptable side effects.