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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00201747

Collaborator

Pharmacia and Upjohn (Industry)

Enrollment

Location

101

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Esophagus Cancer Cancer of Stomach Stomach Cancer	Drug: CPT-11 Drug: Mitomycin C	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Feb 1, 2010

Outcome Measures

Primary Outcome Measures

Most efficacious of two combination regimens of sequential CPT-11 and MMC in patients with advanced and previously untreated esophageal and GE junction adenocarcinomas [2001-2010]

Secondary Outcome Measures

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 [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. [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. [2001-2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.