Trials / Completed
CompletedNCT00021034
Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Phase I Trial of Taurolidine After Positive Second Look Surgery for Recurrent Ovarian Epithelial, Fallopian Tube and Primary Peritoneal Cancers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- Female
- 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. PURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of taurolidine after positive second-look surgery in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. Determine the dose-limiting toxicity and safety of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive taurolidine intraperitoneally weekly on weeks 1-3 and 7-9 in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 weeks for 9 weeks. PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study within 12-18 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | chemotherapy | |
| DRUG | taurolidine |
Timeline
- Start date
- 2001-03-01
- Primary completion
- 2001-08-01
- Completion
- 2001-08-01
- First posted
- 2004-02-16
- Last updated
- 2013-06-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00021034. Inclusion in this directory is not an endorsement.