A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL (TAXOL)
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
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 |
