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

Primary Purpose

Colorectal Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
cisplatin
floxuridine
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
April 4, 2011
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005049
Brief Title
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
Official Title
Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Gastrointestinal Stromal Tumor, Ovarian Cancer, Peritoneal Cavity Cancer, Small Intestine Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
floxuridine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco M. Muggia, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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