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Home > "C" Clinical Trials Conditions > Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer



Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

For Condition: ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI),Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. PURPOSE: Randomizedphase III trial to study the effectiveness of combined carboplatin and paclitaxel with or without continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.
Details: OBJECTIVES: - Compare the progression-free interval and overall survival of patients with early stage ovarian carcinoma treated with carboplatin and paclitaxel with or without low-dose paclitaxel. - Assess the frequency and severity of toxic effects of these regimens in these patients. - Investigate markers of angiogenesis and metastasis as prognostic indicators for early stage ovarian epithelial cancer; more specifically, measure prospectively angiogenic cytokines in urine and plasma and quantify tumor microvessel density in primary ovarian cancer samples. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks. - Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter until death. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types: - Serous adenocarcinoma - Malignant Brenner's tumor - Mucinous adenocarcinoma - Endometrioid - Adenocarcinoma - Clear cell adenocarcinoma - Undifferentiated carcinoma - Transitional cell - Mixed epithelial carcinoma - Adenocarcinoma - not otherwise specified - Completely resected stage I or stage II disease within the past 6 weeks - No tumors of low malignant potential (borderline tumors) PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-3 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times normal - Alkaline phosphatase no greater than 3 times normal - SGOT no greater than 3 times normal Renal: - Creatinine no greater than 2.0 mg/dL Other: - No other invasive malignancies within the past 5 years except nonmelanoma skin cancer - No major systemic medical illness expected to affect survival - Body surface area no greater than 2.0 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No prior treatment for this malignancy except surgical staging - No prior anticancer therapy that would preclude study participation
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertMannel,  Study Chair,  University of Oklahoma College of Medicine

Fred Hutchinson Cancer Research Center *Recruiting*
Seattle,  Washington,  98109-1024
United States
Recruiting Benjamin  Greer 206-685-2463

Fletcher Allen Health Care - Medical Center Campus *Recruiting*
Burlington,  Vermont,  05401
United States
Recruiting Cheung  Wong 802-847-5110

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792-6188
United States
Recruiting Ellen  Hartenbach 608-263-1209

Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19104-4283
United States
Recruiting Mark  Morgan 215-662-6043

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390-9032
United States
Recruiting David  Miller 214-648-3026

H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa,  Florida,  33612-9497
United States
Recruiting James  Fiorica 813-972-8478

Magee-Womens Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15213-3180
United States
Recruiting Joseph  Kelley 412-641-5418

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35294-3300
United States
Recruiting Mack  Barnes 205-934-0930

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

Tufts - New England Medical Center *Recruiting*
Boston,  Massachusetts,  02111
United States
Recruiting Kenneth  Noller 617-636-2382

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0587
United States
Recruiting Edward  Hannigan 409-772-3368

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey,  Pennsylvania,  17033-0850
United States
Recruiting George  Olt 717-531-8144

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1065
United States
Recruiting Brigitte  Miller 336-716-6673

CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Nava  Siegelmann-Danieli 570-271-6834

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Robert  Burger 714-456-7971

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103-1489
United States
Recruiting David  Warshal 856-342-2185

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0526
United States
Recruiting Nader  Husseinzadeh 513-558-8450

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-2516
United States
Recruiting Marta  Crispens 615-322-2114

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Frederick  Ueland 606-257-1613

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting David  Fishman 312-926-7365

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

Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago,  Illinois,  60612-3824
United States
Recruiting Howard  Strassner 312-942-6723

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

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1002
United States
Recruiting Joel  Sorosky 319-356-2015

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Wesley  Fowler 919-966-1196

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Shashikant  Lele 716-845-5776

Cancer Center at the University of Virginia *Recruiting*
Charlottesville,  Virginia,  22908
United States
Recruiting Willie  Andersen 434-924-9333

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5001
United States
Recruiting G.  Rose 202-782-8515

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

Norwegian Radium Hospital *Recruiting*
Oslo,  ,  N-0310
Norway
Recruiting Gunnar  Kristensen 47-22-934-000

Abington Memorial Hospital *Recruiting*
Abington,  Pennsylvania,  19001-3788
United States
Recruiting Parviz  Hanjani 215-885-0220

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Linda  Carson 612-626-3347

University of Oklahoma College of Medicine *Recruiting*
Oklahoma City,  Oklahoma,  73190
United States
Recruiting Robert  Mannel 405-271-8787

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1740
United States
Recruiting Jonathan  Berek 310-206-5161

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44124
United States
Recruiting Peter  Rose 216-444-1712

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Steven  Waggoner 216-844-5011

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Anthony  Evans 715-389-3101

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111
United States
Recruiting Michael  Bookman 215-728-2987

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting S.  Yamada 773-702-6722

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202-5289
United States
Recruiting Katherine  Look 317-274-8987

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62794-9640
United States
Recruiting L.  Massad 217-545-8882

Siteman Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting David  Mutch 314-362

Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville,  Tennessee,  37917
United States
Recruiting Kenneth  Cofer 865-673-9250

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Carol  Brown 212-639-7659

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01605-2982
United States
Recruiting Susan  Zweizig 508-334-1160

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook,  New York,  11790-7775
United States
Recruiting Michael  Pearl 631-444-2774

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Sara  Crowder 573-882-1057

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda,  Maryland,  20892-1182
United States
Recruiting Patient  Recruitment 1-888-NCI-1937

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos,  California,  95032
United States
Recruiting Nick  Spirtos 408-866-3843

Gynecologic Oncology Network *Recruiting*
Nashville,  Tennessee,  37203
United States
Recruiting Howard  Homesley 615-804-2216


Additional Information:
Study ID Numbers:
  CDR0000066732;  GOG-175,SWOG-G0175
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003644

Other Ovarian Epithelial Cancer Studies:
1. Biological Therapy in Treating Patients With Metastatic Cancer

2. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy

3. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer

4. Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

5. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer

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