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Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors



Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: 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 study the effectiveness of paclitaxel plus topotecan in treating patients who have solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and quantitative and qualitative toxic effects of topotecan and paclitaxel in patients with solid tumors. II. Determine the antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of topotecan and paclitaxel. Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan IV continuously on days 1-14. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study within 8-12 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven solid tumor - Measurable or evaluable disease; Measurable disease defined as tumor outside prior radiotherapy fields and reproducibly measurable in 2 dimensions on physical exam, x-ray, CT, or MRI --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent prophylactic hematopoietic growth factors - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Other: No concurrent medications altering cardiac conduction --Patient Characteristics-- - Age: 18 and over - Performance status: 0 or 1 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST less than 3 times normal; Alkaline phosphatase less than 3 times normal - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No poorly controlled angina; No history of congestive heart failure; No myocardial infarction within the past 6 months - Other: Not pregnant or nursing
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HowardHochster,  Study Chair,  Kaplan Cancer Center

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 


Additional Information:
Study ID Numbers:  CDR0000063738;  NYU-9315,NCI-T93-0115D
Study Start Date: September 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002587

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