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Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer



Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer

For Condition: Gastrointestinal Cancer,female reproductive cancer,unclassified and other cancer
Status: Suspended
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
FrancoMuggia,  Study Chair,  Kaplan Cancer Center

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 


Additional Information:
Study ID Numbers:  CDR0000067641;  NYU-9645,NCI-G00-1717
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005049

Other Female Reproductive Cancer Studies:
1. PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer

2. BMS-247550 in Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer

3. Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel

4. Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer

5. Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

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