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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02235

NCT ID:

NCT00002587

Start Date:

September 1994

Completion Date:

December 2000

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016