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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005049
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 6, 2011
National Cancer Institute (NCI)
Information provided by:
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Ovarian Cancer Peritoneal Cavity Cancer Small Intestine Cancer Drug: carboplatin Drug: cisplatin Drug: floxuridine Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Primary Purpose: Treatment
Official Title: Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies
Study Start Date : May 1997
Actual Primary Completion Date : November 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 2 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 1.5 mg/dL
  • SGOT less than 3 times upper limit of normal


  • Creatinine clearance at least 40 mL/min


  • No underlying medical or psychiatric condition that precludes informed consent


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified


  • Not specified


  • Laparoscopy or laparotomy required within 8 weeks of study to assess residual disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005049

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United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
National Cancer Institute (NCI)
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Study Chair: Franco M. Muggia, MD NYU Langone Health

Layout table for additonal information Identifier: NCT00005049     History of Changes
Other Study ID Numbers: CDR0000067641
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: April 2011

Keywords provided by NYU Langone Health:
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

Additional relevant MeSH terms:
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Colorectal Neoplasms
Stomach Neoplasms
Carcinoma, Ovarian Epithelial
Gastrointestinal Stromal Tumors
Peritoneal Neoplasms
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders