Jonathan S. Berek
Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingIntervention(s):
- Drug: cisplatin
- Drug: tirapazamine
- Procedure: brachytherapy
- Procedure: chemosensitization/potentiation
- Procedure: chemotherapy
- Procedure: radiation therapy
- Procedure: radiosensitization
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion 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
* 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
* No prior coronary artery bypass surgery
Other
* No prior cancer therapy that would preclude study treatment
* No concurrent angina medication
Key Exclusion Criteria:
Additional Study Details
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 PelvisAnticipated start date:
2/6/2007Lead Sponsor:
Gynecologic Oncology GroupCollaborator(s):
- National Cancer Institute (NCI)
- National Cancer Institute of Canada
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Recurrence-free survival
- Overall survival
- Local control
Total Number to be Enrolled:
750Total Number to be Enrolled at Stanford:
6More Information
Secondary ID(s):
- 97646
- CAN-NCIC-GOG-0219
- GOG-0219
- GOG0219
- NCT00262821
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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