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

Tracking Information
First Submitted Date ICMJE	April 6, 2000
First Posted Date ICMJE	January 27, 2003
Last Update Posted Date	April 6, 2011
Study Start Date ICMJE	May 1997
Actual Primary Completion Date	November 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00005049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
Official Title ICMJE	Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	Colorectal Cancer; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Gastrointestinal Stromal Tumor; Ovarian Cancer; Peritoneal Cavity Cancer; Small Intestine Cancer
Intervention ICMJE	Drug: carboplatin; Drug: cisplatin; Drug: floxuridine
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 4, 2011)	45
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	November 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00005049
Other Study ID Numbers ICMJE	CDR0000067641; P30CA016087 ( U.S. NIH Grant/Contract ); NYU-9645; NCI-G00-1717
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	New York University School of Medicine
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Franco M. Muggia, MD New York University School of Medicine
PRS Account	New York University School of Medicine
Verification Date	April 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP