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

December 4, 2017 updated by: Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas
Time Frame: 2001-2010
2001-2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate gene expression profile of NQ01, and Topo I genes in peripheral blood mononuclear cells and tumor tissue during therapy with MMC and CPT-11
Time Frame: 2001-2010
2001-2010
Evaluate the frequency of NQ01 gene mutations in patients with esophageal and GE junction adenocarcinomas and its association to prognosis and antitumor activity.
Time Frame: 2001-2010
2001-2010
Evaluate if pre- and/or post-treatment Topo I-, CE and NQ01-gene expression in fresh tumor specimens and adjacent tissue, are associated with antitumor efficacy or toxicity.
Time Frame: 2001-2010
2001-2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

Pharmacia and Upjohn

Investigators

  • Principal Investigator: Miguel Villalona, MD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-0151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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