Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
This study has been completed.
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
First received: April 6, 2000
Last updated: April 4, 2011
Last verified: April 2011
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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 2 |
| 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:
Genetic and Rare Diseases Information Center resources:
Stomach Cancer
Ovarian Cancer
Lymphosarcoma
Ovarian Epithelial Cancer
Carcinoid Tumor
Gastrointestinal Stromal Tumors
Small Intestinal Adenocarcinoma
Leiomyosarcoma
Small Intestine Cancer
Carcinoid Syndrome
Neuroepithelioma
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) |
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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005049
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
| 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:
|
Neoplasms Colorectal Neoplasms Stomach Neoplasms Peritoneal Neoplasms Gastrointestinal Stromal Tumors Carcinoid Tumor Neuroendocrine Tumors 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 Abdominal Neoplasms Peritoneal Diseases Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Cisplatin |
ClinicalTrials.gov processed this record on September 28, 2016