Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

NCT ID: NCT00002587

Last Updated: 2013-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-09-30
• Study Completion Date: 2000-12-31

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Interventions

paclitaxel

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard S. Hochster, MD

Role: STUDY_CHAIR

NYU Langone Health

Locations

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

NYU-9315

Identifier Type: -

Identifier Source: secondary_id

NCI-T93-0115D

Identifier Type: -

Identifier Source: secondary_id

CDR0000063738

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02235

Identifier Type: -

Identifier Source: org_study_id