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Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Clinical research trials and Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer. Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer clinical trial. Subjects frequently get the best healthcare possible for their Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer  Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
For Condition: ovarian clear cell cystadenocarcinoma,Brenner Tumor,ovarian mixed epithelial carcinoma,ovarian mucinous cystadenocarcinoma,ovarian endometrioid adenocarcinoma,peritoneal cavity cancer,ovarian undifferentiated adenocarcinoma,ovarian serous cystadenocarcinoma,Fallopian Tube Cancer,recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
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 I trial to study the effectiveness of topotecan plus etoposide in treating patients who have recurrent ovarian cancer, peritoneal cancer, or fallopian tube cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of sequential prolonged topotecan and prolonged etoposide as second line therapy in patients with recurrent ovarian epithelial, peritoneal, or tubal cancer. II. Determine the nature and degree of toxicity of this treatment regimen in this patient population. III. Evaluate the response rate and time to disease progression in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive oral topotecan daily on days 1-5 and oral etoposide daily on days 8-10. Courses repeat every 28 days in the absence of disease progression or unacceptable side effects. Patients achieving partial or complete response or stable disease continue treatment for at least 4-6 courses. Cohorts of 3-6 patients receive topotecan and etoposide on increasing numbers of days until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no greater than 1 of 6 patients experiences dose limiting toxicity. Patients are followed every 3 months or until death. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed ovarian epithelial, peritoneal, or tubal cancer - Epithelial cell types; Serous adenocarcinoma; Endometrioid adenocarcinoma; Mucinous adenocarcinoma; Undifferentiated carcinoma; Clear cell adenocarcinoma; Mixed epithelial carcinoma; Transitional cell; Malignant; Brenner's tumor; Adenocarcinoma not otherwise specified - Measurable or evaluable disease - No brain or leptomeningeal metastases - No symptomatic bowel involvement of ovarian cancer - Not eligible for higher priority GOG phase II or III study --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy - Chemotherapy: No prior topotecan, other camptothecin analogs, or etoposide; At least 1 prior cisplatin/paclitaxel based regimen; At least 3 weeks since prior chemotherapy and recovered; No more than 2 prior cytotoxic chemotherapy regimens; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy for cancer - Radiotherapy: At least 3 weeks since prior radiotherapy to no more than 10% of the bone marrow and recovered; No concurrent radiotherapy - Other: At least 28 days or 5 half lives since prior investigational drugs (including cytotoxic drugs); No concurrent metoclopramide or cisapride for maintaining gastric motility or emptying; No chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers; Intermittent antacids allowed, if no antacids 6 hours prior to and 90 minutes after topotecan --Patient Characteristics-- - Age: 18 and over - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal; SGOT/SGPT/GGT no greater than 3 times normal; Alkaline phosphatase no greater than 3 times normal; No acute hepatitis - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min - Other: No septicemia or severe infection; Body surface area at least 1 m2; Adequate intestinal function (i.e., does not require IV hydration or nutritional support); Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception 3 months prior to and during study; No other malignancies within the past 5 years except curatively treated skin cancer; No other severe medical problems that would prevent compliance; No condition of the GI tract that would affect GI absorption and motility; No severe gastrointestinal bleeding
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRose, Study Chair, Gynecologic Oncology Group
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Mercy Medical Center, Inc.
Baltimore, Maryland, 21202
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Additional Information:
Study ID Numbers: CDR0000067168; GOG-9807
Study Start Date: September 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003967
Other Brenner Tumor Studies:
1. Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
2. Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
3. Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
4. CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer
5. 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
Related Studies:
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Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
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