Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Recruitment status was Active, not recruiting
|First Received Date ICMJE||July 11, 2001|
|Last Updated Date||April 23, 2011|
|Start Date ICMJE||March 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00021034 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer|
|Official Title ICMJE||Phase I Trial of Taurolidine After Positive Second Look Surgery for Recurrent Ovarian Epithelial, Fallopian Tube and Primary Peritoneal Cancers|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00021034|
|Other Study ID Numbers ICMJE||CDR0000068740, MSKCC-01020, NCI-G01-1976|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Memorial Sloan-Kettering Cancer Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||April 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP