|
Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Clinical research trials and Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum medical trials take place in many of places throughout 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum. Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum clinical trial. Test subjects typically obtain the finest healthcare available for their Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "W" Clinical Trials Conditions > Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum  Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
For Condition: Fallopian Tube Cancer,stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,recurrent ovarian epithelial cancer,peritoneal cavity cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum -based regimens.
Details: OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival in these patients. IV. Assess quality of life in these patients. PROTOCOL OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks. Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience. Patients receive paclitaxel weekly until disease progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study. Quality of life is assessed every cycle for the first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: There will be 100 patients accrued into this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer - Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease; Response that lasted less than 3 months; Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory - Measurable or evaluable disease; Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since immunotherapy; No concurrent immunotherapy - Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule; No other prior chemotherapy besides platinum and paclitaxel; At least 3 weeks since acceptable chemotherapy - Endocrine therapy: At least 3 weeks since hormonal therapy; No concurrent hormonal therapy - Radiotherapy: At least 3 weeks since radiotherapy; No prior radiation to greater than 30% of bone marrow - Surgery: At least 3 weeks since major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST or ALT no greater than 2.5 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No New York Heart Association Class III or IV heart disease; No myocardial infarction within last 6 months; No congestive heart failure; No unstable angina; No clinically significant pericardial effusion or arrhythmia - Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 - Other: No active serious infection or other serious underlying medical condition; No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K; Not pregnant or nursing; Adequate contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaurieMarkman, Study Chair, Theradex
Cancer Center of Santa Barbara
Santa Barbara, California, 93105
United States
Women's Cancer Center of Central PA, P.C.
Harrisburg, Pennsylvania, 17105-8700
United States
Jersey Shore Cancer Center
Neptune, New Jersey, 07753
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Creighton University Cancer Center
Omaha, Nebraska, 68131-2197
United States
Rockwood Clinic P.S.
Spokane, Washington, 99202
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Akron General Medical Center
Akron, Ohio, 44302
United States
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, 45219
United States
Hematology Associates, Ltd.
Phoenix, Arizona, 85013
United States
Oncology Center at Providence Park
Mobile, Alabama, 36608
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, 72703
United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States
Women's Health Center at Albany Medical Center
Albany, New York, 12209
United States
Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: CDR0000065955; THERADEX-B97-3250,NCI-V97-1366,BMS-TAX/MEN.03
Study Start Date: September 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003160
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
2. Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
3. Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
4. Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
5. Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Harrisburg Clinical Trials
Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
|
|
|
|
|
|
|
|
