Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer - Full Text View

Sponsor:	New York University School of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00005049

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	Intervention	Phase
Colorectal Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Ovarian Cancer Peritoneal Cavity Cancer Small Intestine Cancer	Drug: carboplatin Drug: cisplatin Drug: floxuridine	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer Carcinoid Tumors Colorectal Cancer Intestinal Cancer Ovarian Cancer Stomach Cancer

Drug Information available for: Floxuridine Cisplatin Carboplatin

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Enrollment:	45
Study Start Date:	May 1997
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005049

Locations

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

Sponsors and Collaborators

New York University School of Medicine

National Cancer Institute (NCI)

Investigators

Study Chair:

Franco M. Muggia, MD

New York University School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00005049 History of Changes
Other Study ID Numbers:	CDR0000067641, P30CA016087, NYU-9645, NCI-G00-1717
Study First Received:	April 6, 2000
Last Updated:	April 4, 2011
Health Authority:	United States: Federal Government

Keywords provided by New York University School of Medicine:

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

Additional relevant MeSH terms:

Carcinoid Tumor
Colorectal Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Peritoneal Neoplasms
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Intestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neuroendocrine Tumors
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012