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Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00002587
Recruitment Status : Completed
First Posted : May 11, 2004
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: paclitaxel Drug: topotecan hydrochloride Phase 1

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL (TAXOL)
Study Start Date : September 1994
Actual Primary Completion Date : December 2000
Actual Study Completion Date : December 2000

Resource links provided by the National Library of Medicine


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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002587


Locations
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002587     History of Changes
Other Study ID Numbers: NCI-2012-02235
NYU-9315
NCI-T93-0115D
CDR0000063738 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 11, 2004    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: April 2001

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors