Clinical trial NCT00005049: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Franco M. Muggia, MD
role: STUDY_CHAIR
References: