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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
N/A
Not Enrolling
Female
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


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.

Inclusion 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 ≤ 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
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

Type of Study:

Interventional

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:

Yes

Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000306463

NCT ID:

NCT00064077

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Drexel University College of Medicine - Center City Hahnemann CampusPhiladelphia, Pennsylvania  19102
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - OchsnerNew Orleans, Louisiana  70121
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Northwest Community HospitalArlington Heights, Illinois  60005
Memorial Hospital of South BendSouth Bend, Indiana  46601
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Rush University Medical CenterChicago, Illinois  60612-3824
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Gynecologic Oncology NetworkGreenville, North Carolina  27858
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
CCOP - Scott and White HospitalTemple, Texas  76508
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Queens Cancer Center of Queens HospitalJamaica, New York  11432
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
UMDNJ University HospitalNewark, New Jersey  07103
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
University of Tennessee College of MedicineMemphis, Tennessee  38103
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Latter Day Saints HospitalSalt Lake City, Utah  84143
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
Torrance Memorial Medical CenterTorrance, California  90505
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
East Tennessee State University Cancer Center at Johnson City Medical CenterJohnson City, Tennessee  37604
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Cancer Center of Santa BarbaraSanta Barbara, California  93105
Todd Cancer Institute at Long Beach Memorial Medical CenterLong Beach, California  90801
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Baptist Centers for Cancer CareMemphis, Tennessee  38120
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Baptist Regional Cancer Center at Baptist Hospital of East TennesseeKnoxville, Tennessee  37901
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Virginia Oncology Associates - HamptonHampton, Virginia  23666
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Washoe Cancer Services at Washoe Medical Center - RenoReno, Nevada  89502
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Highlands Oncology Group - FayettevilleFayetteville, Arkansas  72703
Washington Regional Medical CenterFayetteville, Arkansas  72703
Colorado Gynecologic Oncology Group P.C.Aurora, Colorado  80010
Woman's HospitalBaton Rouge, Louisiana  70815
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Bon Secours Cancer Institute at St. Mary's HospitalRichmond, Virginia  23226
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Sansum Medical ClinicSanta Barbara, California  93105
University of Virginia Cancer Center at UV Health SystemCharlottesville, Virginia  22908
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa BarbaraSanta Barbara, California  93105
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirmingham, Alabama  35294
Louisville Oncology at Norton Cancer CenterLouisville, Kentucky  40202
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical CenterEdgewood, Kentucky  41017
Piedmont Hematology-Oncology AssociatesWinston-Salem, North Carolina  27103
Saint Mary's Regional Medical CenterReno, Nevada  89503
New York Oncology Hematology, PC at Albany Regional Cancer CareAlbany, New York  12208
Riverview Cancer Care Medical Associates, PCRexford, New York  12148
Good Samaritan Hospital Medical CenterWest Islip, New York  11795
St. Dominic Cancer CenterJackson, Mississippi  39216
Chicago Gynecologic OncologyPalatine, Illinois  60067
New York Oncology Hematology, PC at Albany Medical CenterAlbany, New York  12208
New York Oncology Hematology, PC - HudsonHudson, New York  12534
Virginia Oncology Associates - Lake WrightNorfolk, Virginia  23502