Completed

A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL (TAXOL)

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What is being tested

paclitaxel

+ topotecan hydrochloride

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 1994
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: June 3, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1994

Actual date on which the first participant was enrolled.

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 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.

NCT00002587
Principal SponsorNational Cancer Institute (NCI)
Last updated: June 3, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, United StatesOpen NYU School of Medicine's Kaplan Comprehensive Cancer Center in Google Maps
CompletedOne Study Center