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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Esophagus Cancer, Cancer of Stomach, Stomach Cancer

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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.

Inclusion Criteria:

- Must have pathologically confirmed & measurable advanced esophageal or
Gastroesophageal junction adenocarcinoma

- No prior chemotherapy

- Prior radiation allowed if <=20% of bone marrow was irradiated

- Target lesions must not be in radiation field.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas

Outcome Time Frame:


Safety Issue:


Principal Investigator

Miguel Villalona, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

February 2010

Related Keywords:

  • Esophageal Cancer
  • Esophagus Cancer
  • Cancer of Stomach
  • Stomach Cancer
  • Advanced
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Ohio State UniversityColumbus, Ohio  43210