NCT00005021

Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma

Phase I Evaluation of Topotecan in Combination With Paclitaxel and Carboplatin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining biological therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of topotecan, paclitaxel, and carboplatin with or without filgrastim in treating patients who have advanced solid tumor or lymphoma that has not responded to standard therapy.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated doses of combined topotecan, paclitaxel, and carboplatin (TOPO/TAX/CBDCA) with or without filgrastim (G-CSF) in patients with advanced solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether TAX/CBDCA will affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day 3. IV. Describe any clinical responses observed in these patients. OUTLINE: This is a dose escalation study of the combination topotecan/paclitaxel/carboplatin. Patients are stratified according to prior chemotherapy and radiotherapy (yes vs no). Part I: Patients receive topotecan IV on days 1-3 and paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes, on day 1. Part II: Patients receive topotecan, paclitaxel, and carboplatin as in part I, plus filgrastim (G-CSF) on days 6-19. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of topotecan/paclitaxel/carboplatin 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. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 4 years.

Conditions

• Lymphoma
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	carboplatin
DRUG	paclitaxel
DRUG	topotecan hydrochloride

Timeline

• Start date: 1996-07-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2004-05-03
• Last updated: 2013-07-11

Locations

1 site across 1 country: United States