Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | September 2001 |
| End Date: | February 2010 |
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.
patients with advanced and previously untreated esophageal and GE junction adenocarcinomas.
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.
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.
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.
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