Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborators:	National Cancer Institute (NCI) NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00262821

Purpose

RATIONALE: 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.

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.

Condition	Intervention	Phase
Cervical Cancer	Drug: cisplatin Drug: tirapazamine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

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 [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Local control [ Designated as safety issue: No ]

Estimated Enrollment:	750
Study Start Date:	February 2006
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

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

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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 ≤ ULN or calculated creatinine clearance ≥ 60mL/min

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
No concurrent intensity-modulated radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262821

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

NCIC Clinical Trials Group

Investigators

Study Chair:	Paul A. DiSilvestro, MD	Women and Infants Hospital of Rhode Island
Investigator:	Bradley J. Monk, MD	Chao Family Comprehensive Cancer Center
Study Chair:	Peter S. Craighead, MD	Tom Baker Cancer Centre - Calgary

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00262821 History of Changes
Obsolete Identifiers:	NCT00704873
Other Study ID Numbers:	CDR0000455555, GOG-0219, CAN-NCIC-GOG-0219
Study First Received:	December 6, 2005
Last Updated:	August 5, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer

stage IVA cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases

Genital Diseases, Female
Tirapazamine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2012