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Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian Carcinoma


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

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Trial Information

Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian Carcinoma


OBJECTIVES: I. Determine the maximum tolerated dose of intraperitoneal (IP) gemcitabine
given in combination with IP cisplatin in patients with refractory or recurrent ovarian
epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the safety of this
regimen in this patient population. III. Determine the pharmacokinetics of IP gemcitabine
administered with IP cisplatin.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive intraperitoneal
cisplatin on day 1 plus intraperitoneal gemcitabine on days 1, 8, and 15. No treatment will
be given on day 22. Courses are repeated every 4 weeks. Patients receive up to 4 courses of
therapy. Dose escalation of gemcitabine continues in cohorts of 3 patients until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2
of 6 patients experience dose limiting toxicity (DLT). Patients are followed every 3 months
for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically documented epithelial ovarian carcinoma or
fallopian tube cancer or primary peritoneal cancer following initial cytoreductive surgery
and chemotherapy with at least one cisplatin based chemotherapy regimen Must have
undergone a second assessment procedure (laparoscopy or laparotomy) within 8 weeks of
protocol entry, and have confirmation of residual disease no greater than 1.0 cm at the
end of the procedure

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) SGOT less
than 3 times ULN Alkaline phosphatase less than 3 times ULN Renal: Creatinine less than
1.6 mg/dL Creatinine clearance at least 50 mL/min Other: Must have a functioning implanted
subcutaneous intraperitoneal catheter No neuropathy of grade III or greater from prior
chemotherapy No contraindication to intraperitoneal therapy e.g., intraabdominal infection
or widespread adhesions

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See
Disease Characteristics

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:

97-129

NCT ID:

NCT00003358

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial 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

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021