Clinical trial · Interventional
Tirapazamine, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
A Phase I Study Of Tirapazamine In Combination With Radiation And Weekly Cisplatin In Patients With Locally Advanced Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. Tirapazamine may help cisplatin kill more tumor cells by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Tirapazamine may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy in different ways together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of tirapazamine when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| tirapazamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of tirapazamine
- measure
- Safety and tolerability
Secondary outcomes (5)
- measure
- Failure-free survival
- measure
- Overall survival
- measure
- Patterns of failure for the site of first failure (local-regional, distant, or both)
- measure
- Complete response rate at 12 weeks following study completion
- measure
- Hypoxia by 18F-azomycinarabinoside (FAZA) PET scan at baseline and 12 wks following completion of radiotherapy correlated w/ obj. tumor response by PET- fludeoxyglucose F 18 (FDG) and local-regional failure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available