Brief Title
Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
Phase I Trial Intraperitoneal Cisplatin With Intraperitoneal Gemcitabine in Patients With Epithelial Ovarian Carcinoma
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of cisplatin plus gemcitabine in treating
patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary
peritoneal cancer.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
chemotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
January 1998
Primary Completion Date
January 2001
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Sabbatini, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003358
Organization ID
97-129
Secondary IDs
MSKCC-97129
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Paul Sabbatini, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
January 2013