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Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube 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 Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Clinical research trials and Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube 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 Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer. Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube 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 Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube 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 > "A" Clinical Trials Conditions > Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer  Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
For Condition: ovarian epithelial cancer,Fallopian Tube Cancer,peritoneal cavity cancer
Status: Not yet recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining adjuvantintraperitoneal carboplatin with paclitaxel in treating patients who have undergone debulking surgery for stage III or stage IV ovarian epithelial, primaryperitoneal, or fallopian tube cancer.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel in patients with stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery. - Determine the feasibility of this regimen in these patients. Secondary - Determine the toxicity profile of this regimen in these patients. - Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin. Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose escalation and 20-40 for feasibility) will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer - Stage III or IV disease - The following histologic epithelial cell types are eligible: - Serous adenocarcinoma - Mucinous adenocarcinoma - Clear cell adenocarcinoma - Transitional cell carcinoma - Adenocarcinoma not otherwise specified - Endometrioid adenocarcinoma - Undifferentiated carcinoma - Mixed epithelial carcinoma - Malignant Brenner's tumor - Optimal ( 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks) - Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true: - Stage IB disease or less - Less than 3 mm invasion without vascular or lymphatic invasion - No poorly differentiated subtypes, including the following: - Papillary serous - Clear cell - Other FIGO grade 3 lesions - No epithelial tumors of low malignant potential (borderline tumors) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - No active bleeding Hepatic - AST 3 times upper limit of normal (ULN) - Alkaline phosphatase 3 times ULN - Bilirubin 1.5 times ULN - No acute hepatitis Renal - Creatinine 2.0 mg/dL Cardiovascular - No unstable angina - No myocardial infarction within the past 6 months - Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for at least 6 months before study entry Other - No neuropathy (sensory and motor) > grade 1 - No active infection requiring antibiotics - No circumstances that would preclude study participation - No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 3 years since prior adjuvant chemotherapy for localized breast cancer - Patients must remain free of recurrent or metastatic disease Endocrine therapy - Not specified Radiotherapy - At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin - Patient must remain free of recurrent or metastatic disease - No prior radiotherapy to any portion of the abdominal cavity or pelvis Surgery - See Disease Characteristics Other - No prior therapy for this malignancy - No prior cancer treatment that contraindicates study therapy - No concurrent amifostine or other protective agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkMorgan, Study Chair, University of Pennsylvania Cancer Center
Additional Information:
Study ID Numbers: CDR0000355741; GOG-9917
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079430
Other Fallopian Tube Cancer Studies:
1. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
2. UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
4. Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
5. Cetuximab, Paclitaxel, and Carboplatin in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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