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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Tirapazamine, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
Scientific title
A Phase I Study Of Tirapazamine In Combination With Radiation And Weekly Cisplatin In Patients With Locally Advanced Cervical Cancer
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Study type
Description of intervention(s) / exposure
Treatment: Drugs - cisplatin
Treatment: Drugs - tirapazamine
Treatment: Other - brachytherapy
Treatment: Other - radiation therapy

Treatment: Drugs: cisplatin

Treatment: Drugs: tirapazamine

Treatment: Other: brachytherapy

Treatment: Other: radiation therapy

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Maximum tolerated dose of tirapazamine
Timepoint [1] 0 0
Primary outcome [2] 0 0
Safety and tolerability
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Failure-free survival
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Patterns of failure for the site of first failure (local-regional, distant, or both)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Complete response rate at 12 weeks following study completion
Timepoint [4] 0 0
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0

Key inclusion criteria

- 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



- Any age

Performance status

- ECOG 0-2

Life expectancy

- More than 6 months


- Absolute neutrophil count = 1,500/mm^3

- Platelet count = 100,000/mm^3


- Bilirubin < 1.25 times upper limit of normal (ULN)

- AST and ALT = 3 times ULN


- Calculated creatinine clearance = 60 mL/min OR

- Glomerular filtration rate = 60 mL/min


- 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


- 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


Biologic therapy

- No concurrent epoetin alfa

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

- No concurrent pegfilgrastim


- No prior chemotherapy for another malignancy

Endocrine therapy

- Not specified


- 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


- Not specified


- 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
Minimum age
No limit
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
8006 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Peter MacCallum Cancer Centre, Australia
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Danny Rischin, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications