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Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer Clinical research trials and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer. Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer  Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
For Condition: recurrent ovarian epithelial cancer,peritoneal cavity 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. PURPOSE: Phase I trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine the safety and tolerability of intraperitoneal administration of paclitaxel (Paclimer microspheres) in patients with recurrent or persistent ovarian or primary peritoneal carcinoma. II. Determine and confirm the maximum tolerated dose of this regimen in this patient population. III. Determine plasma paclitaxel concentrations at selected times after intraperitoneal administration of Paclimer microspheres in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive intraperitoneal paclitaxel (Paclimer microspheres) every 8 weeks for 2 courses. Cohorts of 1-3 patients receive escalating doses of intraperitoneal paclitaxel (Paclimer microspheres) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. Once the probable MTD is determined, an additional cohort of 8 patients is accrued to confirm the MTD. The MTD is confirmed as the dose level at which at least 6 of 8 patients demonstrate acceptable safety and tolerability. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Recurrent or persistent ovarian and/or primary peritoneal carcinoma - Adequate potential intraperitoneal fluid distribution with no gross fluid loculations and adhesions that would significantly affect intraperitoneal drug distribution --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea and mitomycin) and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy to major bone marrow containing areas - Surgery: Not specified - Other: At least 1 month since other prior investigational agents --Patient Characteristics-- - Age: 21 and over - Performance status: GOG 0-2 - Life expectancy: At least 6 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal - Renal: Creatinine less than 2.0 mg/dL - Other: No other sufficiently severe medical problems unrelated to malignancy that would preclude study compliance or cause exposure to undue risks; No prior unmanageable reaction to paclitaxel
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeborahArmstrong, Study Chair, Gynecologic Oncology Group
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Additional Information:
Study ID Numbers: CDR0000067638; GOG-9904,GP-700-9901
Study Start Date: April 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005046
Other Peritoneal Cavity Cancer Studies:
1. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
2. Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
3. Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
4. Aminocamptothecin in Treating Patients With Recurrent or Unresectable Epithelial Ovarian Cancer
5. Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
Related Studies:
Other peritoneal cavity cancer Clinical Trials
Other California Clinical Trials
Other Orange Clinical Trials
Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
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