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Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005049 |
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 |
Study Start Date: | May 1997 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
New York, New York, United States, 10016 |
Study Chair: | Franco M. Muggia, MD | New York University School of Medicine |
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 |
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 |
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 |
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 |