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A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix

Phase 3
18 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix


- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- GOG 0-1

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times normal

- Alkaline phosphatase no greater than 3 times normal

- AST no greater than 3 times normal


- Creatinine ≤ 1.2 mg/dL OR

- Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min

- No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior or concurrent malignancy within the past 5 years except nonmelanoma skin

- No prior malignancy whose treatment contraindicates the current study therapy

- No concurrent clinically significant infection


Biologic therapy

- No concurrent cytokines


- At least 6 weeks since prior chemoradiotherapy and recovered

- No prior chemotherapy (except when concurrently administered with radiotherapy)

Endocrine therapy

- Not specified


- See Disease Characteristics

- See Chemotherapy

- At least 3 weeks since prior radiotherapy and recovered


- Recovered from prior surgery

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale at baseline, courses 2 and 5, and 9 months after completion of study treatment

Safety Issue:


Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • Uterine Cervical Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
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University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
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Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
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CCOP - Kansas City Kansas City, Missouri  64131
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George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
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Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
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Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Drexel University College of Medicine - Center City Hahnemann Campus Philadelphia, Pennsylvania  19102
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Ochsner New Orleans, Louisiana  70121
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
Northwest Community Hospital Arlington Heights, Illinois  60005
Memorial Hospital of South Bend South Bend, Indiana  46601
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
Rush University Medical Center Chicago, Illinois  60612-3824
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Gynecologic Oncology Network Greenville, North Carolina  27858
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
CCOP - Scott and White Hospital Temple, Texas  76508
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
University of California Davis Cancer Center Sacramento, California  95817
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
UCSF Comprehensive Cancer Center San Francisco, California  94115
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
UMDNJ University Hospital Newark, New Jersey  07103
SUNY Downstate Medical Center Brooklyn, New York  11203
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
University of Tennessee College of Medicine Memphis, Tennessee  38103
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
Latter Day Saints Hospital Salt Lake City, Utah  84143
Long Island Jewish Medical Center New Hyde Park, New York  11040
Yale Cancer Center New Haven, Connecticut  06520-8028
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
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Torrance Memorial Medical Center Torrance, California  90505
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
East Tennessee State University Cancer Center at Johnson City Medical Center Johnson City, Tennessee  37604
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Cancer Center of Santa Barbara Santa Barbara, California  93105
Todd Cancer Institute at Long Beach Memorial Medical Center Long Beach, California  90801
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Women's Cancer Center - Lake Mead Las Vegas, Nevada  89102
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
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Hope A Women's Cancer Center Asheville, North Carolina  28801
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Baptist Centers for Cancer Care Memphis, Tennessee  38120
Moores UCSD Cancer Center La Jolla, California  92093-0658
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter, Florida  33458
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Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Knoxville, Tennessee  37901
UMC Southwest Cancer and Research Center Lubbock, Texas  79415-3364
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Virginia Oncology Associates - Hampton Hampton, Virginia  23666
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Washoe Cancer Services at Washoe Medical Center - Reno Reno, Nevada  89502
Leo W. Jenkins Cancer Center at ECU Medical School Greenville, North Carolina  27834
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Highlands Oncology Group - Fayetteville Fayetteville, Arkansas  72703
Washington Regional Medical Center Fayetteville, Arkansas  72703
Colorado Gynecologic Oncology Group P.C. Aurora, Colorado  80010
Woman's Hospital Baton Rouge, Louisiana  70815
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst, North Carolina  28374
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140
Bon Secours Cancer Institute at St. Mary's Hospital Richmond, Virginia  23226
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Sansum Medical Clinic Santa Barbara, California  93105
University of Virginia Cancer Center at UV Health System Charlottesville, Virginia  22908
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara Santa Barbara, California  93105
Stanford Comprehensive Cancer Center - Stanford Stanford, California  94305
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham Birmingham, Alabama  35294
Louisville Oncology at Norton Cancer Center Louisville, Kentucky  40202
Good Samaritan Hospital Cancer Treatment Center Cincinnati, Ohio  45220
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center Edgewood, Kentucky  41017
Piedmont Hematology-Oncology Associates Winston-Salem, North Carolina  27103
Saint Mary's Regional Medical Center Reno, Nevada  89503
New York Oncology Hematology, PC at Albany Regional Cancer Care Albany, New York  12208
Riverview Cancer Care Medical Associates, PC Rexford, New York  12148
Good Samaritan Hospital Medical Center West Islip, New York  11795
St. Dominic Cancer Center Jackson, Mississippi  39216
Chicago Gynecologic Oncology Palatine, Illinois  60067
New York Oncology Hematology, PC at Albany Medical Center Albany, New York  12208
New York Oncology Hematology, PC - Hudson Hudson, New York  12534
Virginia Oncology Associates - Lake Wright Norfolk, Virginia  23502