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Spots Global Cancer Trial Database for Rebeccamycin Analog and Oxaliplatin in Treating Patients With Refractory Solid Tumors

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Trial Identification

Brief Title: Rebeccamycin Analog and Oxaliplatin in Treating Patients With Refractory Solid Tumors

Official Title: A Phase I Study of XL119 (Rebeccamycin Analogue) in Combination With Oxaliplatin in Patients With Refractory Solid Tumors

Study ID: NCT00086983

Study Description

Brief Summary: This phase I trial is studying the side effects and best dose of rebeccamycin analog and oxaliplatin in treating patients with refractory solid tumors. Drugs used in chemotherapy, such as rebeccamycin analog and oxaliplatin, work in 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: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of XL119 given in conjunction with oxaliplatin. II.To determine the dose limiting toxicities of this combination. III. To determine the pharmacokinetics of these 2 agents when given in combination. OUTLINE: This is a dose-escalation study. Patients receive rebeccamycin analogue IV over 1 hour on days 1-5 and oxaliplatin IV over 2 hours on day 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. Patients are followed annually for survival.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Case Western Reserve University, Cleveland, Ohio, United States

Contact Details

Name: Afshin Dowlati

Affiliation: Case Western Reserve University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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