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Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Clinical research trials and Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer. Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer  Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
For Condition: peritoneal cavity cancer,ovarian epithelial cancer,Fallopian Tube Cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining polyglutamate paclitaxel with carboplatin in treating women who have ovarian epithelial, peritoneal, or fallopian tube cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of polyglutamate paclitaxel in combination with carboplatin in patients with chemotherapy-naïve ovarian epithelial, primary peritoneal, or fallopian tube carcinoma. - Determine the feasibility of this regimen at the MTD in an expanded cohort of patients. - Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort. - Determine the toxicity profile of this regimen in these patients. - Determine the pharmacokinetics and pharmacodynamics of this drug combination in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study of polyglutamate paclitaxel (CT-2103) followed by a feasibility, multicenter study. - Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CT-2103 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment. - Feasibility phase: Once the MTD of CT-2103 is determined, an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 3-88 patients (3-48 for dose-escalation phase and 20-40 for feasibility phase) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma - Stage III or IV - Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery - The following histologic epithelial cell types are eligible: - Serous adenocarcinoma - Mucinous adenocarcinoma - Clear cell adenocarcinoma - Transitional cell carcinoma - Adenocarcinoma not otherwise specified - Endometrioid adenocarcinoma - Undifferentiated carcinoma - Mixed epithelial carcinoma - Malignant Brenner tumor - No epithelial tumors of low malignant potential (borderline tumors) - Surgery performed within the past 12 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No active bleeding Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis) - Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis) - No acute hepatitis - PT and PTT normal Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for the past 6 months - No myocardial infarction within the past 6 months - No unstable angina Other - Not pregnant or nursing - Fertile patients must use effective contraception - No neuropathy (sensory or motor) grade 2 or worse - No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast cancer - No active infection requiring antibiotics - No circumstances that would preclude study completion or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease) Endocrine therapy - Not specified Radiotherapy - More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin (must be free of recurrent or metastatic disease) - No prior radiotherapy to any portion of the abdominal cavity or pelvis Surgery - See Disease Characteristics Other - No prior treatment, other than debulking surgery, for this cancer - No prior treatment for another cancer that would contraindicate this protocol therapy - No concurrent amifostine or other protective reagents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkMorgan, Study Chair, University of Pennsylvania Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Steven Waggoner 216-844-5011
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103-1489
United States
Recruiting David Warshal 856-342-2185
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Mark Morgan 215-662-6043
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting S. Yamada 773-702-6722
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1002
United States
Recruiting Joel Sorosky 319-356-2015
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Michael Bookman 215-728-2987
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6188
United States
Recruiting Ellen Hartenbach 608-263-1209
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Warren Grant Magnuson Clinical Center *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient Recruitment 800-411-1222
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
University of Oklahoma College of Medicine *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting Robert Mannel 405-271-8787
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Andrew Menzin 516-562-4438
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Carol Brown 212-639-7659
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Anthony Evans 715-389-3101
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44124
United States
Recruiting Peter Rose 216-444-1712
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1740
United States
Recruiting Jonathan Berek 310-206-5161
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Katherine Look 317-274-8987
Additional Information:
Study ID Numbers: CDR0000301642; GOG-9914
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060359
Other Ovarian Epithelial Cancer Studies:
1. Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
2. Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk
3. 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
4. CA-125 in Screening Patients at High Risk for Ovarian Cancer
5. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
Related Studies:
Other ovarian epithelial cancer Clinical Trials
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Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
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