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Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix


Phase 3
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix


OBJECTIVES:

- Compare the overall survival, progression-free survival, and objective response rate
(confirmed and unconfirmed, complete and partial) of patients with recurrent,
persistent, or metastatic cervical cancer treated with cisplatin and paclitaxel vs
cisplatin and gemcitabine.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a
radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic
disease). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2
hours on day 2.

- Arm II:Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV
over 2 hours on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this
study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging
criteria:

- Metastatic (stage IVB)

- Recurrent after prior complete response to primary treatment with surgery or
radiotherapy

- Persistent after surgery or radiotherapy

- Measurable disease

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Creatinine less than upper limit of normal OR

- Creatinine clearance greater than 40 mL/min

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No grade 2 or greater sensory or motor neuropathy

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 6 months since prior single-agent chemotherapy as a radiosensitizer

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- At least 28 days since prior radiotherapy

- No prior radiotherapy to measurable target lesions

- No concurrent palliative radiotherapy

Surgery

- See Disease Characteristics

- Recovered from prior surgery

Other

- No prior systemic therapy

- No other concurrent antitumor therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Harry J. Long, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000285630

NCT ID:

NCT00057928

Start Date:

April 2003

Completion Date:

July 2003

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Loyola University Medical CenterMaywood, Illinois  60153
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
University of California Davis Cancer CenterSacramento, California  95817
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Oregon Cancer InstitutePortland, Oregon  97201-3098
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Barrett Cancer CenterCincinnati, Ohio  45267-0502
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Mayo ClinicJacksonville, Florida  32224
Western New York Urology AssociatesBuffalo, New York  14220
James P. Wilmot Cancer Center at the University of Rochester Medical CenterRochester, New York  14642