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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00005049
First received: April 6, 2000
Last updated: April 4, 2011
Last verified: April 2011

April 6, 2000
April 4, 2011
May 1997
November 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005049 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Colorectal Cancer
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Gastrointestinal Stromal Tumor
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Small Intestine Cancer
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: floxuridine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005049
CDR0000067641, P30CA016087, NYU-9645, NCI-G00-1717
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New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Franco M. Muggia, MD New York University School of Medicine
New York University School of Medicine
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP