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Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer


OBJECTIVES: I. Evaluate the survival of patients with metastatic or recurrent epithelial
squamous or adenosquamous carcinoma of the cervix when treated with intravenous tirapazamine
plus intravenous cisplatin. II. Evaluate the unconfirmed complete and partial response rates
of these patients, as well as, the nature and degree of toxicity associated with this
regimen in this patient population.

OUTLINE: Patients receive tirapazamine intravenously over 2 hours and then, following a 1
hour rest, receive cisplatin intravenously over 1 hour. Courses are repeated every 21 days.
Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease
progression. All patients are followed every 6 months for 2 years, then annually thereafter
until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed squamous or adenosquamous carcinoma of
the cervix that is metastatic, recurrent, or refractory Any stage disease treated with
prior radical surgery and/or definitive radiotherapy that has locally recurred and is no
longer amenable to surgery or radiotherapy OR Metastatic disease that is not amenable to
surgery or radiation therapy Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal
Other: No history of allergic reaction to mannitol Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception during and for 3 months
after study No other prior malignancy except: Adequately treated basal cell or squamous
cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer from
which the patient is currently in complete remission Any other cancer from which the
patient has been disease free for 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factor
therapy Chemotherapy: Prior chemotherapy (hydroxyurea, fluorouracil, metronidazole,
cisplatin, or other platinum agent) allowed as a radiosensitizing agent only No other
concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics Prior radiotherapy allowed to less than 30% of the bone marrow only
Recovered from toxic effects No concurrent radiotherapy Surgery: See Disease
Characteristics Prior surgery allowed Recovered from effects of prior surgery Other: No
prior systemic therapy for this disease

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

From date of registration to date of death due to any cause

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Harriet O. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of New Mexico Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066358

NCT ID:

NCT00003369

Start Date:

August 1998

Completion Date:

July 2004

Related Keywords:

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

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
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
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
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
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
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
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
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
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 - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
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
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
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
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
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209