Trials / Completed
CompletedNCT00003331
Combination Chemotherapy in Treating Patients With Advanced Cancer
A Phase I Study of Low Dose Continuous Infusion Topotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of combining topotecan, fluorouracil, and leucovorin in treating patients who have advanced cancer.
Detailed description
OBJECTIVES: I. Evaluate the maximum tolerated dose (MTD) of continuous infusion topotecan in combination with fluorouracil for patients with advanced malignancy and establish a recommended phase II dose based on the MTD. II. Evaluate the dose limiting toxicity of this combination in these patients. II. Obtain pharmacokinetic and pharmacodynamic data for topoisomerase-1 depletion in patients receiving this treatment. IV. Identify any objective tumor responses arising from this treatment in these patients. OUTLINE: This is a dose-escalation study of topotecan in combination with fluorouracil. Patients receive topotecan as a 24-hour continuous infusion on days 1-14 in combination with fluorouracil IV and leucovorin calcium IV on days 1-5; course repeats every 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. In the absence of dose limiting toxicity (DLT) in the first cohort of 3 patients treated, subsequent cohorts each receive escalating doses on the same schedule. If DLT is observed in 2 of 3 patients or 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.
Conditions
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Precancerous Condition
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluorouracil | |
| DRUG | leucovorin calcium | |
| DRUG | topotecan hydrochloride |
Timeline
- Start date
- 1998-01-01
- Primary completion
- 2001-11-01
- First posted
- 2004-09-13
- Last updated
- 2011-03-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00003331. Inclusion in this directory is not an endorsement.