Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies
18 Years
N/A
Both
Colorectal Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Gastrointestinal Stromal Tumor, Ovarian Cancer, Peritoneal Cavity Cancer, Small Intestine Cancer
Trial Information
Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Franco M. Muggia, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000067641
NCT ID:
NCT00005049
Start Date:
May 1997
Completion Date:
Related Keywords:
- Colorectal Cancer
- Gastric Cancer
- Gastrointestinal Carcinoid Tumor
- Gastrointestinal Stromal Tumor
- Ovarian Cancer
- Peritoneal Cavity Cancer
- Small Intestine Cancer
- stage II colon cancer
- stage III colon cancer
- stage II gastric cancer
- stage III gastric cancer
- recurrent gastric cancer
- stage II rectal cancer
- stage III rectal cancer
- recurrent colon cancer
- stage III ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- regional gastrointestinal carcinoid tumor
- small intestine adenocarcinoma
- small intestine lymphoma
- small intestine leiomyosarcoma
- recurrent small intestine cancer
- peritoneal cavity cancer
- gastrointestinal stromal tumor
- Carcinoid Tumor
- Colorectal Neoplasms
- Stomach Neoplasms
- Ovarian Neoplasms
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Peritoneal Neoplasms
- Malignant Carcinoid Syndrome
- Gastrointestinal Neoplasms
- Gastrointestinal Stromal Tumors
- Intestinal Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|---|
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
