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Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer. Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer  Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
For Condition: stage 3 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 2 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Rigshospitalet ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00) - Evaluate the anti-tumor activity of this regimen in this patient population. OUTLINE: This is a multicenter, dose-escalation study of topotecan. Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. - Phase I: Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00) - Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer - Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients) - No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Hemoglobin at least 9.0 g/dL - WBC at least 3,500/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present - Alkaline phosphatase no greater than 2 times ULN* - SGOT no greater than 2 times ULN* NOTE: *No greater than 5 times ULN if liver metastases present Renal: - Creatinine no greater than 1.5 times ULN - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment - No myocardial infarction within the past 3 months Other: - No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix - No uncontrolled infection - No complete bowel obstruction or other condition that would affect GI absorption or motility - No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated - No other concurrent medical conditions that would preclude study - No mental disease - No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K) - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy Chemotherapy: - No prior camptothecin analogue - No prior chemotherapy for ovarian cancer - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - No concurrent hormonal therapy other than estrogen replacement Radiotherapy: - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - At least 30 days or 5 half-lives since any prior investigational therapy - No other concurrent investigational therapy - No concurrent metoclopramide or cisapride
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SvendEngelholm, Study Chair, Rigshospitalet
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Svend Engelholm 45-35454088
Additional Information:
Study ID Numbers: CDR0000066847; DAN-104864/373,DAN-104864-A/373,EU-98052,SB-104864-A/373,SB-104864/373
Study Start Date:
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003732
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
2. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
3. Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
4. Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
5. Quality-of-Life Assessment in Patients With Ovarian Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other Clinical Trials
Other Copenhagen Clinical Trials
Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
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