Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase I Trial of Taurolidine After Positive Second Look Surgery for Recurrent Ovarian Epithelial, Fallopian Tube and Primary Peritoneal Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021034
• Other study ID #: 01-020
• Secondary ID: CDR0000068740NCI
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2001
• Last updated: June 17, 2013
• Start date: March 2001
• Est. completion date: August 2001

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2001
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal adenocarcinoma Stage IIC or higher at diagnosis Successfully received prior chemotherapy Undergone initial cytoreductive surgery Evidence of gross disease at second-look surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST and/or ALT less than 3 times upper limit of normal No clinically significant PT/PTT abnormality Renal: Creatinine less than 1.7 mg/dL Other: No known hypersensitivity to taurolidine or its excipients No other clinically significant disease that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• chemotherapy

• taurolidine

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,