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Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, June 2008

Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
National Cancer Institute (NCI)
Gynecologic Oncology Group
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00704873
  Purpose

The purpose of this study is to determine if combining a drug called Tirapazamine (TPZ) with cisplatin during radiation therapy increases progression-free survival (PSF) compared with cisplatin alone and radiation therapy for the treatment of cancer of the cervix. Progression-free survival is one type of measurement that can be used in a clinical study or trial to help determine whether a new treatment is effective. It refers to the probability that a patient will remain alive, without the disease getting worse.

The study will also determine if the addition of Tirapazamine to cisplatin and radiation therapy improves progression-free survival and the type of side-effects that occur with the addition of Tirapazamine to cisplatin in patients with cancer of the cervix.


Condition Intervention Phase
Cervical Cancer
Drug: cisplatin
Drug: tirapazamine
Phase III

MedlinePlus related topics:   Cancer    Cervical Cancer   

ChemIDplus related topics:   Cisplatin    Tirapazamine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:   A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: After completion of study treatment, patients will be followed for five years ] [ Designated as safety issue: No ]

Estimated Enrollment:   750
Study Start Date:   February 2006
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
Drug: cisplatin

given intravenously for Arm 1:Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).

For Arm II: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29

2: Experimental
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.
Drug: cisplatin

given intravenously for Arm 1:Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).

For Arm II: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29

Drug: tirapazamine
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix

    • Stage IB2, IIA, IIB, IIIB, or IVA disease
    • Stage IIA tumors must be > 4 cm
    • Primary, untreated disease
  • Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or lymphadenectomy
  • Must have been adequately clinically staged
  • Suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiotherapy
  • No disease involvement of the lower third of the vagina regardless of stage (all stage IIIA, IIIB and IVA with lower one-third involvement)
  • No carcinoma of the cervical stump

PATIENT CHARACTERISTICS:

PERFORMANCE STATUS

  • GOG 0-3 LIFE EXPECTANCY
  • Not specified HEMATOPOIETIC
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3 HEPATIC
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN RENAL
  • Creatinine ≤ 2.0 mg/dL CARDIOVASCULAR
  • No New York Heart Association class III-IV heart failure
  • No history of myocardial infarction
  • No unstable angina
  • No uncontrolled hypertension OTHER
  • No pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No septicemia or severe infection
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

SURGERY

  • No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy
  • No prior coronary artery bypass surgery OTHER
  • No prior cancer therapy that would preclude study treatment
  • No concurrent angina medication
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704873

Contacts
Contact: Bernadetter Cracchiolo, MD, MPH     9739725055     cracchbm@umdnj.edu    
Contact: Yasmeen S Barber, BA     9739727789     barberys@umdnj.edu    

Locations
United States, New Jersey
Univeristy of Medicine and Dentistry of New Jersey     Recruiting
      Newark, New Jersey, United States, 07101-1709
      Contact: Yasmeen S. Barber, BA     973-972-7789     barberys@umdnj.edu    
      Sub-Investigator: Margarette Bryan            
      Principal Investigator: Bernadette Cracchiolo, MD, MPH            
      Sub-Investigator: Dolly Razdan, MD            
      Sub-Investigator: Debra Heller, MD            

Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
National Cancer Institute (NCI)
Gynecologic Oncology Group

Investigators
Study Chair:     PAUL A. DiSILVESTRO, M.D.     Women and Infants' Hospital    
  More Information


Responsible Party:   Women and Infants Hospital anf Univ of California-Irvine respectively ( PAUL A. DiSILVESTRO, M.D. and BRADLEY MONK, M.D., Study Co-Chairs )
Study ID Numbers:   0120050332
First Received:   June 23, 2008
Last Updated:   June 23, 2008
ClinicalTrials.gov Identifier:   NCT00704873
Health Authority:   United States: Food and Drug Administration;   United States: Institutional Review Board;   United States: Gynecologic Oncology Group;   United States: National Cancer Institute

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Cisplatin
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Tirapazamine
Urogenital Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008




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