Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: oxaliplatin

• Registration Number: NCT00004242
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors. 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.

Detailed Description

OBJECTIVES:

I. Determine the maximum tolerated dose, recommended phase II dose, and associated toxic effects of the triple combination of continuous infusion fluorouracil, weekly gemcitabine, and oxaliplatin in patients with metastatic or unresectable solid tumors.

II. Define sequence dependent toxic effects, if any, and establish pharmacokinetic and pharmacodynamic relationships in context of this triple combination chemotherapy in this patient population.

OUTLINE: This is a dose-escalation study of oxaliplatin and gemcitabine.

For course 1, and then course 3 and beyond, patients receive oxaliplatin IV over 2 hours on day 1, followed by gemcitabine IV over 30 minutes on days 1 and 8, and then fluorouracil IV continuously on days 1-14. For course 2, patients receive treatment in the same manner as in course 1, except gemcitabine is given initially, followed by oxaliplatin, and then fluorouracil. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine 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. The recommended phase II dose (RPTD) is defined as the dose preceding MTD.

Once RPTD is defined, the cohort is expanded to an additional 13 patients. These patients receive a fixed dose of oxaliplatin, gemcitabine, and fluorouracil as determined by the phase I dose escalation portion of this study.

Patients are followed for disease progression.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2000-01-28
• Status Verified: 2002-07
• Primary Completion: 2003-12
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	fluorouracil	See detailed description.
Arm I	gemcitabine hydrochloride	See detailed description.
Arm I	oxaliplatin	See detailed description.

Trial Locations

Locations (2)

NYU School of Medicine's Kaplan Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Albert Einstein Comprehensive Cancer Center; 🇺🇸 Bronx, New York, United States