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


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

01-020

NCT ID:

NCT00021034

Start Date:

March 2001

Completion Date:

August 2001

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021