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A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin Clinical research trials and A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin. A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin  A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin
A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin
For Condition: Ovarian Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The objectives of this study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.
Details: This is a Phase II study of 9-aminocamptothecin (9-AC), administered as an intravenous continuous infusion over 72 hours with G-CSF support for patients with advanced refractory ovarian cancer. The objectives of the present study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Histologically proven, advanced epithelial ovarian cancer. Histologic confirmation by Pathology Department, NIH, required. Recurrent disease after paclitaxel and either cisplatin or carboplatin. Combination platinum/paclitaxel acceptable. Bidimensionally measurable disease on physical exam, radiographs, or peritoneoscopy. Repeat peritoneoscopy after 8 courses of therapy required if documentation of disease was solely by peritoneoscopy. Laparotomy not required. No CNS metastasis. No borderline or mixed histology. PRIOR/CONCURRENT THERAPY: See Disease Characteristics. More than 4 weeks since any prior therapy and recovered. No prior camptothecin analogue-based chemotherapy. No prior radiotherapy except intraperitoneal 32-P. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0-2. Hematopoietic: WBC greater than 3,000. AGC greater than 1,500. Platelets at least 100,000. Hemoglobin greater than 9 g/dL OR; Hematocrit greater than 27 g/dL. Hepatic: Bilirubin no greater than 1.5 mg/dL. Serum transaminases no greater than 2 times normal. Renal: 24-hour creatinine clearance greater than 45 mL/min (documented by NCI investigator or primary care physician). Cardiovascular: No myocardial infarction within 12 months. No active congestive heart failure. No heart block. No arrhythmia requiring medication. OTHER: No active uncontrolled infection. No known HIV positivity. No second malignancy currently under treatment except: Local basal cell carcinoma of the skin, Cervical carcinoma in situ, Other malignancies (e.g., stage I breast cancer) eligible at the discretion of the principal or associate investigators. No pregnant women.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950056; 95-C-0056
Study Start Date: January 18, 1995
Record last reviewed: January 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001427
Other Ovarian Neoplasms Studies:
1. Study of Motexafin Gadolinium and Docetaxel for Advanced Solid Tumors
2. Tandem cycles of high dose chemotherapy followed by stem cell support for ovarian cancer
3. Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer
4. Phase 3 Study of TLK286 vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer
5. Massage Therapy for Cancer-Related Fatigue
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A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin with G-CSF Support in Patients with Advanced Ovarian Cancer Previously Treated with Paclitaxel and Cisplatin
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