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

This study has been completed.
Sponsor:
Collaborator:
Pharmacia and Upjohn
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201747
First received: September 12, 2005
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Esophageal Cancer
Esophagus Cancer
Cancer of Stomach
Stomach Cancer
Drug: CPT-11
Drug: Mitomycin C
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

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 [ Time Frame: 2001-2010 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 2001-2010 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2001
Study Completion Date: February 2010
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201747

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Pharmacia and Upjohn
Investigators
Principal Investigator: Miguel Villalona, MD Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Miguel Villalona, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201747     History of Changes
Other Study ID Numbers: OSU-0151
Study First Received: September 12, 2005
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
Advanced

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Mitomycins
Mitomycin
Irinotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014