Status:
COMPLETED
Tirapazamine, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Eligibility:
FEMALE
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as tirapazamine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tira...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and the recommended phase II and III dose of tirapazamine when combined with cisplatin and radiotherapy in patients with Stage IB-IVA squam...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
- Stage IB, IIA, IIB, III, or IVA disease
- No evidence of involvement of para-aortic nodes by CT scan, MRI, fluorodeoxyglucose positron emission tomography, or lymphadenectomy
- Involvement of common iliac nodes allowed
- No evidence of distant metastases
- PATIENT CHARACTERISTICS:
- Age
- Any age
- Performance status
- ECOG 0-2
- Life expectancy
- More than 6 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin \< 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Renal
- Calculated creatinine clearance ≥ 60 mL/min OR
- Glomerular filtration rate ≥ 60 mL/min
- Cardiovascular
- No significant cardiac disease that would preclude IV fluid load required for administration of cisplatin
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Other
- No symptomatic peripheral neuropathy ≥ grade 2
- No clinically significant sensori-neural hearing impairment interfering with activities of daily living or requiring a hearing aid
- Audiometric changes alone of any severity allowed
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to tirapazamine or cisplatin
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent epoetin alfa
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- No concurrent pegfilgrastim
- Chemotherapy
- No prior chemotherapy for another malignancy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior pelvic or abdominal radiotherapy for another malignancy
- No prior radiotherapy to ≥ 15% of bone marrow-bearing areas
- No concurrent intensity-modulated radiotherapy
- No concurrent interstitial brachytherapy
- Surgery
- Not specified
- Other
- No prior treatment for invasive cervical cancer
- No other concurrent therapeutic investigational agents
- No other concurrent anticancer therapy
- No concurrent systemic retinoids
- No concurrent amifostine
- No concurrent combination antiretroviral therapy for HIV-positive patients
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00098995
Start Date
December 1 2004
End Date
January 1 2010
Last Update
June 26 2013
Active Locations (2)
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1
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 8006
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9