Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

May 31, 2013 updated by: National Cancer Institute (NCI)

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

Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients who have solid tumors. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I

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.
Drug: paclitaxel
Drug: topotecan hydrochloride

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1994

Primary Completion (Actual)

December 1, 2000

Study Completion (Actual)

December 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 10, 2004

First Posted (Estimate)

May 11, 2004

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

April 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02235
  • NYU-9315
  • NCI-T93-0115D
  • CDR0000063738 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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