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Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer Clinical research trials and Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer. Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer  Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer
Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,ovarian mixed epithelial carcinoma,ovarian endometrioid adenocarcinoma,ovarian serous cystadenocarcinoma,ovarian mucinous cystadenocarcinoma,stage 3 ovarian epithelial cancer,ovarian clear cell cystadenocarcinoma
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill more tumor cells. PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor.
Details: OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on progression free survival, overall survival, safety, response, and CA-125 levels in patients with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer. PROTOCOL OUTLINE: This is a randomized, open label, multicenter study. Patients receive treatment of IV paclitaxel and IV carboplatin. Patients are randomized to one of two treatment groups: Arm I: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Courses are repeated every 21 days. Arm II: Patients receive IV paclitaxel over 3 hours, immediately followed by IV carboplatin, on day 1. Patients receive intraperitoneal SCH 58500 on days 1-5. Courses are repeated every 21 days. Patients are followed every 6 weeks for 36 months, then every 3 months for 2 years, and then every 6 months until disease progression. PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for 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 ovarian epithelial or primary peritoneal cancer with residual disease no greater than 2 cm following cytoreductive surgery - The following cell types are eligible: Serous adenocarcinoma, mucinous adenocarcinoma, clear cell adenocarcinoma, transitional cell, adenocarcinoma NOS, endometrioid adenocarcinoma, mixed epithelial carcinoma, or peritoneal serous papillary carcinoma - Total abdominal hysterectomy with salpingo-oophorectomy or supracervical hysterectomy, omentectomy, tumor reduction, lymph node assessment, and debulking if nodes 2 cm or greater - No endometrial malignancy treated with supracervical hysterectomy - No cytologically positive pleural effusion - No tumors of borderline histology - No cancer of the fallopian tubes --Prior/Concurrent Therapy-- - Biologic therapy: Concurrent cytokine therapy allowed - Chemotherapy: No more than 1 prior chemotherapy course for ovarian or peritoneal cancer; At least 10 years since prior adjuvant chemotherapy for breast cancer - Endocrine therapy: At least 3 months since prior systemic corticosteroid or other immunosuppressive therapy; Concurrent female hormonal replacement allowed - Radiotherapy: No prior radiotherapy for ovarian or peritoneal cancer; No prior radiotherapy to abdomen - Surgery: Prior surgery allowed - Other: No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 80-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil 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) SGOT no greater than 2 times ULN; Alkaline phosphatase no greater than 2 times ULN - Renal: Creatinine no greater than 2 mg/dL; Glomerular filtration rate no less than 30 - Other: HIV negative; Not pregnant or nursing; Fertile patients must use effective contraception; No other serious medical condition; No other prior malignancies except carcinoma in situ of the cervix, nonmelanomatous skin cancer, Dukes A colorectal cancer from which patient has been disease free for past 5 years, or stage I or II breast cancer from which patient has been disease free for past 10 years
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoHorowitz, Study Chair, Schering-Plough
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
G. Rainey Williams Pavilion
Oklahoma City, Oklahoma, 73190
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
Texas Oncology, P.A.
Dallas, Texas, 75246
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Woman's Hospital
Baton Rouge, Louisiana, 70895-9009
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Southeastern Gynecologic Oncology
Decatur, Georgia, 30033
United States
Wesley Medical Center
Wichita, Kansas, 67214
United States
Loma Linda University Cancer Institute
Loma Linda, California, 92354
United States
Mercy Cancer Institute
Pittsburgh, Pennsylvania, 15219
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Pacific Gynecology Specialists
Seattle, Washington, 98104
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225
United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
Providence Hospital Cancer Center
Southfield, Michigan, 48075
United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32804
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Rocky Mountain Gynecologic Oncology
Englewood, Colorado, 80110
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
New York Medical College
Valhalla, New York, 10595
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Greenville Hospital System
Greenville, South Carolina, 29605
United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
United States
Additional Information:
Study ID Numbers: CDR0000067047; SPRI-C/I98-102,NCI-V99-1544,SPRI-C98-102
Study Start Date: February 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003880
Other Ovarian Mixed Epithelial Carcinoma Studies:
1. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
2. TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
3. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
4. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
5. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
Related Studies:
Other ovarian mixed epithelial carcinoma Clinical Trials
Other New Mexico Clinical Trials
Other Albuquerque Clinical Trials
Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer
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