Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00005068
• Lead Sponsor: Mayo Clinic

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to determine the effectiveness of two different regimens of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen vs Mayo regimen) plus oxaliplatin (arm I vs arm II) in patients with metastatic or unresectable solid tumors. II. Determine the effect of irinotecan on the disposition of oxaliplatin in these patients. III. Assess the development of peripheral neuropathy in these patients on the Mayo regimen. IV. Determine the activity of these regimens in patients with metastatic solid tumors.

OUTLINE: This is a dose escalation study. Patients are entered to one of two treatment arms: Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22, followed by oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 6 weeks. Arm II (Mayo regimen): Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1, followed by leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks. Cohorts of 3-6 patients receive escalating doses of fluorouracil (one of two treatment doses for arm II), and one of two treatment doses of irinotecan and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for 3 months.

PROJECTED ACCRUAL: Up to 60 patients will be accrued for this study within 8-14 months.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2000-04-06
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted QC: 2004-04-01
• Study First Posted: 2004-04-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States