Tirapazamine, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

NCT00098995 | Completed Phase 1

• 3 other identifiers: PMCC-2004/354CDR0000393978NCI-5485
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 2

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. 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

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of tirapazamine

• Safety and tolerability

Secondary Outcomes (5)

• Failure-free survival

• Overall survival

• Patterns of failure for the site of first failure (local-regional, distant, or both)

• Complete response rate at 12 weeks following study completion

• 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

Interventions

cisplatin DRUG

tirapazamine DRUG

brachytherapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 8006, Australia

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Tirapazamine; Brachytherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Danny Rischin, MD

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: December 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 26, 2013

Record last verified: 2006-11

Locations

AU (1); CA (1)