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Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Clinical research trials and Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer  Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
For Condition: stage 3 ovarian epithelial cancer,peritoneal cavity cancer,Fallopian Tube Cancer,recurrent ovarian epithelial cancer,stage 1 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 2 ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and irinotecan in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
Details: OBJECTIVES: I. Evaluate the antitumor effect of weekly cisplatin and irinotecan in patients with suboptimally debulked ovarian, fallopian tube, or peritoneal cancer and persistently elevated serum values of CA125 after 3 courses of standard therapy with paclitaxel and either carboplatin or cisplatin. II. Evaluate the toxicity, both qualitative and quantitative, of this regimen in this patient population. III. Evaluate the quality of life of these patients. PROTOCOL OUTLINE: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90 minutes. Treatment is administered weekly for 4 weeks (days 1, 8, 15, and 22) followed by 2 weeks of rest. Patients receive at least 3 courses (18 weeks) of therapy in the absence of disease progression or unacceptable toxicity. If patients demonstrate complete response to treatment, they are encouraged to undergo second-look laparoscopy or laparotomy. Quality of life is assessed before treatment, after the first course, and then after every 2 courses of therapy. Patients are followed 30 days after the last treatment and then for survival. PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 18-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed epithelial carcinoma of the ovary, fallopian tube, or peritoneum - At least 3 prior courses of standard platinum-paclitaxel regimen; Patients with taxane allergy may enter this study after 3 courses of platinum based treatment - CA125 at least 35 measured within 30 days of commencement of treatment - Measurable disease not required - No CNS metastases, carcinomatous meningitis or interstitial pulmonary fibrosis --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy - Chemotherapy: No prior irinotecan or topotecan - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to the pelvis - Surgery: At least 4 weeks since prior surgery and recovered - Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL; Calcium less than 12.0 mg/dL - Cardiovascular: No unstable angina; No New York Heart Association grade III or IV cardiac disease - Pulmonary: See Disease Characteristics - Other: No active or uncontrolled infection; No history of seizures; No known Gilbert's Disease; No medical or psychiatric conditions that makes patient a poor risk for participation in this study; Not pregnant or lactating; Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidSpriggs, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000066322; MSKCC-97121,NCI-H98-0013
Study Start Date: October 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003345
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
2. Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Ovarian Cancer or Primary Peritoneal Cancer in Remission Following Surgery and Chemotherapy
4. Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
5. Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
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