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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 May 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00262821
First received: December 6, 2005
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.


Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
 Drug: cisplatin
Drug: tirapazamine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine (IND #46525) and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: February 2006
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (cisplatin)
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
 Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Experimental: Arm II (cisplatin, tirapazamine)
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 IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: tirapazamine
Given IV
Other Names:
  • SR 4233
  • Tirazone
  • WIN 59075

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN
  • Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min
  • No New York Heart Association class III-IV heart failure
  • No history of myocardial infarction
  • No unstable angina
  • No uncontrolled hypertension
  • 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
  • No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy
  • No prior coronary artery bypass surgery
  • No prior cancer therapy that would preclude study treatment
  • No concurrent angina medication
  • No concurrent intensity-modulated radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262821

  Show 282 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Investigators
Principal Investigator: Paul DiSilvestro Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262821     History of Changes
Obsolete Identifiers: NCT00704873
Other Study ID Numbers: NCI-2009-00591, GOG-0219, CAN-NCIC-GOG-0219, CDR0000455555, U10CA027469
Study First Received: December 6, 2005
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
 Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Tirapazamine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013