Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002587

Enrollment

Registered

2004-05-11

Start date

1994-09-30

Completion date

2000-12-31

Last updated

2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

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.

Interventions

DRUGpaclitaxel

DRUGtopotecan hydrochloride

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026