Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Gastrointestinal Stromal Tumor, Ovarian Cancer, Peritoneal Cavity Cancer, Small Intestine Cancer

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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