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

September 12, 2005
December 18, 2012
September 2001
October 2006   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00201747 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Esophageal and Stomach Cancer
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Esophagus Cancer
  • Cancer of Stomach
  • Stomach Cancer
  • 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)
Not Provided
Lustberg MB, Bekaii-Saab T, Young D, Otterson G, Burak W, Abbas A, McCracken-Bussa B, Lustberg ME, Villalona-Calero MA. Phase II randomized study of two regimens of sequentially administered mitomycin C and irinotecan in patients with unresectable esophageal and gastroesophageal adenocarcinoma. J Thorac Oncol. 2010 May;5(5):713-8. doi: 10.1097/JTO.0b013e3181d7776d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2010
October 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201747
OSU-0151
Yes
Miguel Villalona, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Pharmacia and Upjohn
Principal Investigator: Miguel Villalona, MD Ohio State University
Ohio State University Comprehensive Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP