Know Cancer

forgot password

Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer

Phase 2
18 Years
Not Enrolling
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:


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:


Principal Investigator

Harriet O. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Federal Government

Study ID:




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



Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209