Ovarian Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
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 and giving them by intraperitoneal infusion may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of intraperitoneal combination chemotherapy in treating patients who have stage III ovarian epithelial cancer or gastrointestinal cancer.
Full Description
OBJECTIVES:
Assess tolerance and complications from consolidation therapy with intraperitoneal floxuridine and cisplatin and/or carboplatin in patients with stage III ovarian epithelial cancer or gastrointestinal cancer with peritoneal involvement.
Determine the sites of failure and estimate the time to failure following treatment with this regimen in these patients.
OUTLINE: Patients are stratified according to type of residual disease at second look laparotomy or laparoscopy (micro only vs no greater than 0.5 cm vs greater than 0.5 cm and no greater than 1 cm), and by CA-125 level (elevated vs normal on day -7).
Patients receive intraperitoneal floxuridine on days 1-3 followed by intraperitoneal cisplatin and/or carboplatin on day 3. Treatment continues every 3 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 and 6 weeks, then at 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage III ovarian epithelial cancer or gastrointestinal cancer with peritoneal involvement
Patients with ovarian cancer must have completed first induction treatment with a platinum based regimen (carboplatin and/or cisplatin) and be in clinical complete response at time of assessment for study
No ovarian cancer of low malignant potential
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
Greater than 2 months
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin less than 1.5 mg/dL
SGOT less than 3 times upper limit of normal
Renal:
Creatinine clearance at least 40 mL/min
Other:
No underlying medical or psychiatric condition that precludes informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
See Disease Characteristics
At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Laparoscopy or laparotomy required within 8 weeks of study to assess residual disease
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There is 1 Location for this study
New York New York, 10016, United States
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