Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

Launched by NATIONAL CANCER INSTITUTE (NCI) · May 10, 2004

Keywords

ClinConnect Summary

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.

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 u...

Gender

ALL

Eligibility 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
• PATIENT CHARACTERISTICS:
• • Age: 18 and over
• • Performance status: 0 or 1
• • Life expectancy: At least 12 weeks
• • WBC at least 4,000/mm3
• • Platelet count at least 100,000/mm3
• • Bilirubin no greater than 1.5 mg/dL
• • AST less than 3 times normal
• • Alkaline phosphatase less than 3 times normal
• • Creatinine no greater than 1.5 mg/dL
• • No poorly controlled angina
• • No history of congestive heart failure
• • No myocardial infarction within the past 6 months
• • Not pregnant or nursing
• PRIOR CONCURRENT THERAPY:
• • No concurrent prophylactic hematopoietic growth factors
• • No concurrent medications altering cardiac conduction

Trial Officials