Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors - Full Text View

Purpose

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	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: paclitaxel Drug: topotecan hydrochloride	Phase 1

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL (TAXOL)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Enrollment:	20
Study Start Date:	September 1994
Study Completion Date:	December 2000
Primary Completion Date:	December 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received:	November 1, 1999
Last Updated:	May 31, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms
Paclitaxel
Topotecan
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013