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

Colorectal Cancer Clinical Trial

Official title:

Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005049
• Other study ID #: CDR0000067641
• Secondary ID: P30CA016087NYU-9
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: April 4, 2011
• Start date: May 1997

Study information

• Verified date: April 2011
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Colorectal Cancer
• Gastric Cancer
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Malignant Carcinoid Syndrome
• Neoplasms, Glandular and Epithelial
• Neuroendocrine Tumors
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms
• Small Intestine Cancer
• Stomach Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• floxuridine

Locations

Country	Name	City	State
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,