Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer
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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 |
- 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 ]
- 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) |
-
Drug: CPT-11
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 |
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| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| 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 Diseases Esophageal Neoplasms Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Stomach Diseases Mitomycins Mitomycin Irinotecan |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013