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Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer

NCT00201747 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-12-06

No results posted yet for this study

Summary

To determine the most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas.

Conditions

  • Esophageal Cancer
  • Esophagus Cancer
  • Cancer of Stomach
  • Stomach Cancer

Interventions

DRUG

CPT-11

CPT-11 will be administered intravenously on days 2 and 9 (24 hours after MMC, when the MMC is required) Two weeks of rest (beginning days 15 and 22) (drug free) will complete the cycle, with therapy planned to be resumed on day 29.

DRUG

Mitomycin C

MMC will be administered intravenously on day 1 (Arm A) and days 1 and 8 (Arm B)

Sponsors & Collaborators

  • Pharmacia and Upjohn

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Miguel Villalona, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2006-10-31
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201747 on ClinicalTrials.gov