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Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal 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 Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Clinical research trials and Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal 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 Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer. Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal 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 Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal 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 > "T" Clinical Trials Conditions > Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer  Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
For Condition: stage 4 ovarian epithelial cancer,peritoneal cavity cancer,Fallopian Tube Cancer,stage 3 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Beth Israel Deaconess Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primaryperitoneal cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy. - Determine the safety of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression. Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients. Patients are followed every 2 months for at least 6 months. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer - Stage IIIB, IIIC, or IV - Surgically staged and debulked - Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria: - No evidence of cancer by history or physical examination - CA 125 no greater than 35 units/mL - No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray - Must have received at least 5 courses of first-line chemotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,200/mm^3 - Platelet count at least 90,000/mm^3 Hepatic - Bilirubin normal - ALT and AST less than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase less than 1.5 ULN Renal - Creatinine clearance at least 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - At least 3 weeks since prior first-line chemotherapy - At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer) - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy Radiotherapy - No prior abdominopelvic radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - No concurrent surgery Other - No other concurrent antitumor therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenCannistra, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Stephen Cannistra 617-667-4283
Additional Information:
Study ID Numbers: CDR0000269138; BIDMC-E-010405FB,NEDH-E-010405FB
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055614
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
2. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
3. Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
4. High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery
5. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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