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

Sponsors and Collaborators:	New York University School of Medicine National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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:	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:

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 National Cancer Institute (NCI):

Study Start Date:

May 1997

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

Study ID Numbers:	CDR0000067641, NYU-9645, NCI-G00-1717
Study First Received:	April 6, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00005049 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Rectal Neoplasms
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Ileal Diseases
Duodenal Neoplasms
Peritoneal Diseases
Ovarian Cancer
Neuroepithelioma
Endocrine Gland Neoplasms
Carcinoid Syndrome
Digestive System Neoplasms
Floxuridine
Genital Neoplasms, Female
Endocrine System Diseases

Carboplatin
Malignant Carcinoid Syndrome
Carcinoma
Neuroectodermal Tumors
Gastrointestinal Neoplasms
Carcinoid Tumor
Stomach Cancer
Neoplasms, Glandular and Epithelial
Antimetabolites
Leiomyosarcoma
Gastrointestinal Diseases
Gonadal Disorders
Ovarian Diseases
Genital Diseases, Female
Stomach Diseases

Additional relevant MeSH terms:

Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Ileal Diseases
Duodenal Neoplasms
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Digestive System Neoplasms
Floxuridine
Genital Neoplasms, Female

Endocrine System Diseases
Malignant Carcinoid Syndrome
Carboplatin
Carcinoma
Neuroectodermal Tumors
Neoplasms
Gastrointestinal Neoplasms
Carcinoid Tumor
Neoplasms, Glandular and Epithelial
Antimetabolites
Gastrointestinal Diseases
Gonadal Disorders
Antineoplastic Agents
Neoplasms, Nerve Tissue
Ovarian Diseases

ClinicalTrials.gov processed this record on July 02, 2009