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

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ClinicalTrials.gov Identifier: NCT00005049

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : April 6, 2011

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

New York University School of Medicine

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.

Condition or disease	Intervention/treatment	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 2

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
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
Study Start Date :	May 1997
Actual Primary Completion Date :	November 2006

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gastrointestinal stromal tumor

Drug Information available for: Floxuridine Carboplatin

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Stomach Cancer Carcinoid Tumor Ovarian Cancer Gastrointestinal Stromal Tumors Ovarian Epithelial Cancer Leiomyosarcoma Small Intestine Cancer Small Intestinal Adenocarcinoma Carcinoid Syndrome Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


ClinicalTrials.gov Identifier:	NCT00005049 History of Changes
Other Study ID Numbers:	CDR0000067641 P30CA016087 ( U.S. NIH Grant/Contract ) NYU-9645 NCI-G00-1717
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	April 6, 2011
Last Verified:	April 2011

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:


Neoplasms Colorectal Neoplasms Stomach Neoplasms Gastrointestinal Stromal Tumors Peritoneal Neoplasms Carcinoid Tumor Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases	Rectal Diseases Stomach Diseases Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Abdominal Neoplasms Peritoneal Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Cisplatin

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