- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003369
S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer
Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of tirapazamine plus cisplatin in treating patients who have metastatic, recurrent, or refractory cervical cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36688
- MBCCOP - University of South Alabama
-
-
Arizona
-
Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
-
Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
-
Tucson, Arizona, United States, 85724
- Arizona Cancer Center
-
Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
-
-
California
-
Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
-
Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, United States, 91010
- Beckman Research Institute, City of Hope
-
Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
-
Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
-
Sacramento, California, United States, 95817
- University of California Davis Medical Center
-
San Francisco, California, United States, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
-
Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
-
-
Georgia
-
Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
-
Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
-
-
Illinois
-
Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
-
Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
-
Kansas
-
Kansas City, Kansas, United States, 66160-7357
- University of Kansas Medical Center
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
-
-
Kentucky
-
Lexington, Kentucky, United States, 40511-1093
- Veterans Affairs Medical Center - Lexington
-
Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
-
New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
-
Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
-
Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
-
Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
-
Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids Clinical Oncology Program
-
Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
-
-
Mississippi
-
Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
-
Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
-
Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
-
Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
-
-
Missouri
-
Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
-
Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
-
Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
-
-
Montana
-
Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
-
Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
-
-
New York
-
Brooklyn, New York, United States, 11209
- Veterans Affairs Medical Center - Brooklyn
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Barrett Cancer Center, The University Hospital
-
Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Cancer Center
-
Columbus, Ohio, United States, 43206
- CCOP - Columbus
-
Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
-
Kettering, Ohio, United States, 45429
- CCOP - Dayton
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
-
Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
-
-
Oregon
-
Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
-
Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
-
Galveston, Texas, United States, 77555-1329
- University of Texas Medical Branch
-
Lubbock, Texas, United States, 79423
- Texas Tech University Health Science Center
-
San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, United States, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
-
Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- Huntsman Cancer Institute
-
Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
-
-
Washington
-
Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
-
Seattle, Washington, United States, 98104
- Swedish Cancer Institute
-
Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
-
Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tirapazamine/cisplatin
tirapazamine and cisplatin given Day 1 of each 21-day treatment cycle
|
75 mg/m2 IV as a one-hour infusion after tirapazamine on Day 1 of each 21-day cycle
Other Names:
260 mg/m2 over two hours prior to cisplatin on Day 1 of each 21-day cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 6 months
|
From date of registration to date of death due to any cause
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Harriet O. Smith, MD, University of New Mexico Cancer Center
Publications and helpful links
General Publications
- Smith HO, Jiang CS, Weiss GR, Hallum AV 3rd, Liu PY, Robinson WR 3rd, Cheng PC, Scudder SA, Markman M, Alberts DS. Tirapazamine plus cisplatin in advanced or recurrent carcinoma of the uterine cervix: a Southwest Oncology Group study. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):298-305. doi: 10.1111/j.1525-1438.2006.00339.x.
- Smith HO, Jiang C, Weiss GR, et al.: Tirapazamine plus cisplatin in advanced or recurrent squamous or adenosquamous carcinoma of the uterine cervix: a phase II study of the Southwest Oncology Group. [Abstract] Gynecol Oncol 92 (1): A-49, 416, 2004.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066358
- U10CA032102 (U.S. NIH Grant/Contract)
- SWOG-S9717 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on cisplatin
-
West China Second University HospitalRecruitingNeoadjuvant Chemotherapy | Epithelial Carcinoma, OvarianChina
-
Insmed IncorporatedCompletedOsteosarcoma MetastaticUnited States
-
Privo TechnologiesNational Cancer Institute (NCI)CompletedOral Squamous Cell CarcinomaUnited States
-
Samsung Medical CenterUnknownNasophayngeal Carcinoma Between Stage II and IVbKorea, Republic of
-
Cedars-Sinai Medical CenterRecruitingHPV Positive Oropharyngeal Squamous Cell CarcinomaUnited States
-
Korea Cancer Center HospitalCompletedCervical CancersKorea, Republic of
-
Taiho Oncology, Inc.Quintiles, Inc.Completed
-
Sun Yat-sen UniversityActive, not recruitingNasopharyngeal CarcinomaChina
-
Lawson Health Research InstituteRecruitingLocally Advanced Head and Neck Squamous Cell CarcinomaCanada
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People... and other collaboratorsActive, not recruitingNasopharyngeal Carcinoma | Nasopharyngeal Neoplasms | Nasopharyngeal Diseases | Head and Neck NeoplasmChina