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Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix Clinical research trials and Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix. Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix clinical trial. Subjects frequently obtain the most expert healthcare possible for their Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.

Home > "C" Clinical Trials Conditions > Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix



Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

For Condition: cervical adenocarcinoma,cervical adenosquamous cell carcinoma,cervical squamous cell carcinoma,stage 4B cervical cancer,recurrent cervical cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapyregimen containing cisplatin is most effective in treating cervical cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of four combination chemotherapy regimens using cisplatin in treating women who have stage IVB, recurrent, or persistent cancer of the cervix.
Details: OBJECTIVES: - Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin. - Compare the toxic effects of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. - Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. - Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. - Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix - Stage IVB, recurrent, or persistent disease - Not amenable to curative surgery and/or radiotherapy - At least 1 unidimensionally measurable lesion - At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan - Biopsy confirmation required if lesion is less than 30 mm - Target lesion must be outside of a previously irradiated field - No craniospinal metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/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 - AST no greater than 3 times normal Renal - Creatinine no greater than 1.2 mg/dL OR - Creatinine greater than 1.2 mg/dL but less than 1.5 mg/dL AND creatinine clearance greater than 50 mL/min - No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage Other - Not pregnant or nursing - Fertile patients must use effective contraception - No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer - No prior malignancy whose treatment contraindicates the current study therapy - No concurrent clinically significant infection PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent cytokines Chemotherapy - At least 6 weeks since prior chemoradiotherapy and recovered - No prior chemotherapy (except when concurrently administered with radiotherapy) Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - See Chemotherapy - At least 3 weeks since prior radiotherapy and recovered Surgery - Recovered from prior surgery
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BradleyMonk,  Study Chair,  Chao Family Comprehensive Cancer Center

Tom Baker Cancer Center - Calgary *Recruiting*
Calgary,  Alberta,  T2N 4N2
Canada
Recruiting Gavin  Stuart 403-944-1721

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

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

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905-0001
United States
Recruiting Harry  Long 507-284-4320

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

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

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

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

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

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

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

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

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver,  Colorado,  80010
United States
Recruiting Francis  Major 303-388-4876

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

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

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

Yale Comprehensive Cancer Center *Recruiting*
New Haven,  Connecticut,  06520-8028
United States
Recruiting Peter  Schwartz 203-785-4014

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

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting Jeffrey  Fowler 614-293-8737

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

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

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

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

Clinical Genetics Branch *Recruiting*
Rockville,  Maryland,  20852-7231
United States
Recruiting Mark  Greene 301-594-7642

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

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

Tacoma General Hospital *Recruiting*
Tacoma,  Washington,  98405
United States
Recruiting Roger  Lee 253-403-1029

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

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

CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha,  Nebraska,  68106
United States
Recruiting James  Mailliard 402-280-4364

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

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

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

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

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

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

Saint Joseph Regional Medical Center *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting Michael  Method 574-237-8010

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

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

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

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

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

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

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

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

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Charles  Levenback 713-745-2563

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

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Daniel  Clarke-Pearson 919-684-3765

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

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

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

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

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Andrew  Menzin 516-562-4438

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19107-5541
United States
Recruiting Stephanie  King 215-762-2640

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

Australia New Zealand Gynaecological Oncology Trials Group *Recruiting*
Camperdown,  New South Wales,  1450
Australia
Recruiting Michael  Friedlander 61-2-9562-1450

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

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

Radiation Oncology Branch *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Alan  Epstein 301-496-5457

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

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

State University of New York at Stony Brook School of Medicine *Recruiting*
Stony Brook,  New York,  11794
United States
Recruiting Michael  Pearl 631-444-2774

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

Kagoshima City Hospital *Recruiting*
Kagoshima City,  ,  892-8580
Japan
Recruiting Masayuki  Hatae 81-99-224-2101

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

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

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

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

Keesler Medical Center - Keesler Air Force Base *Recruiting*
Keesler AFB,  Mississippi,  39534-2576
United States
Recruiting John  Bomalaski 228-377-6396

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

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

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

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

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

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

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


Additional Information:
Study ID Numbers:
  CDR0000306463;  GOG-0204
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064077

Other Recurrent Cervical Cancer Studies:
1. Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer

2. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer

3. Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

4. Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

5. Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix

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Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

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