|
Paclitaxel in Treating Women With Recurrent Solid Tumors Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Paclitaxel in Treating Women With Recurrent Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Paclitaxel in Treating Women With Recurrent Solid Tumors Clinical research trials and Paclitaxel in Treating Women With Recurrent Solid Tumors healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Paclitaxel in Treating Women With Recurrent Solid Tumors. Paclitaxel in Treating Women With Recurrent Solid Tumors Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Paclitaxel in Treating Women With Recurrent Solid Tumors clinical trial. Human subjects often obtain the finest healthcare possible for their Paclitaxel in Treating Women With Recurrent Solid Tumors condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Women With Recurrent Solid Tumors  Paclitaxel in Treating Women With Recurrent Solid Tumors
Paclitaxel in Treating Women With Recurrent Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors.
Details: OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects, BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these patients. PROTOCOL OUTLINE: Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician. PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven recurrent adult solid tumors - Must have measurable or evaluable disease - No known bone marrow metastasis --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior paclitaxel therapy; No more than 1 prior chemotherapy regimen for metastatic disease; At least 4 weeks since chemotherapy; Greater than 6 weeks since nitrosoureas, melphalan, or mitomycin - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since radiotherapy; No prior whole pelvic radiation - Surgery: At least 4 weeks since major surgery --Patient Characteristics-- - Age: 18 and over - Sex: Women - Performance Status: Zubrod 0-2 - Life Expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT less than 2.0 times upper limit of normal - Renal: Creatinine no greater than 1.5 times upper limit of normal - Other: Concurrently active secondary malignancies are allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntoniusMiller, Study Chair, Cancer and Leukemia Group B
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Additional Information:
Study ID Numbers: CDR0000065893; CLB-9763
Study Start Date: November 1997
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003130
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. UCN-01 and Cisplatin in Treating Patients With Advanced Solid Tumors
2. Dexmethylphenidate in Treating Patients With Fatigue and Behavior Change After Chemotherapy
3. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
4. Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Paclitaxel in Treating Women With Recurrent Solid Tumors
|
|
|
|
|
|
|
|
