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Phase II Trial of Cisplatin and Irinotecan in Patients With Suboptimally Debulked, Incompletely Responding Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

Phase II Trial of Cisplatin and Irinotecan in Patients With Suboptimally Debulked, Incompletely Responding Ovarian Cancer

OBJECTIVES: I. Evaluate the antitumor effect of weekly cisplatin and irinotecan in patients
with suboptimally debulked ovarian, fallopian tube, or peritoneal cancer and persistently
elevated serum values of CA125 after 3 courses of standard therapy with paclitaxel and
either carboplatin or cisplatin. II. Evaluate the toxicity, both qualitative and
quantitative, of this regimen in this patient population. III. Evaluate the quality of life
of these patients.

OUTLINE: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90
minutes. Treatment is administered weekly for 4 weeks (days 1, 8, 15, and 22) followed by 2
weeks of rest. Patients receive at least 3 courses (18 weeks) of therapy in the absence of
disease progression or unacceptable toxicity. If patients demonstrate complete response to
treatment, they are encouraged to undergo second-look laparoscopy or laparotomy. Quality of
life is assessed before treatment, after the first course, and then after every 2 courses of
therapy. Patients are followed 30 days after the last treatment and then for survival.

PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 18-24 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of the ovary,
fallopian tube, or peritoneum At least 3 prior courses of standard platinum-paclitaxel
regimen Patients with taxane allergy may enter this study after 3 courses of platinum
based treatment CA125 at least 35 measured within 30 days of commencement of treatment
Measurable disease not required No CNS metastases, carcinomatous meningitis or
interstitial pulmonary fibrosis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine
no greater than 1.5 mg/dL Calcium less than 12.0 mg/dL Cardiovascular: No unstable angina
No New York Heart Association grade III or IV cardiac disease Pulmonary: See Disease
Characteristics Other: No active or uncontrolled infection No history of seizures No known
Gilbert's Disease No medical or psychiatric conditions that makes patient a poor risk for
participation in this study Not pregnant or lactating Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy to the pelvis Surgery: At least 4 weeks since prior surgery and recovered
Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

October 2001

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



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