Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: topotecan hydrochloride; Drug: paclitaxel

Study type: Interventional

Funder types: NIH

Identifiers

NCT00002587

NYU-9315

NCI-T93-0115D

CDR0000063738 (Registry Identifier)

NCI-2012-02235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Drug: topotecan hydrochloride

Drug: paclitaxel