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


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Cancer Clusters


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

This study has been suspended.

Sponsors and Collaborators: Kaplan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
female reproductive cancer
Gastrointestinal Cancer
unclassified and other cancer
 Drug: carboplatin
 Drug: cisplatin
 Drug: floxuridine
 Procedure: chemotherapy
 Procedure: intraperitoneal therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Digestive Diseases;   Reproductive Health

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Pilot Study of Consolidation Therapy With Intraperitoneal Floxuridine and Cisplatin and/or Carboplatin in Patients With Stage III Ovarian Epithelial or Gastrointestinal Cancer

Further Study Details: 

OBJECTIVES:

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Location Information


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

Study chairs or principal investigators

Franco M. Muggia, MD,  Study Chair,  Kaplan Cancer Center   

More Information

Study ID Numbers:  CDR0000067641; NYU-9645; NCI-G00-1717
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005049
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: November 22, 2004
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