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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00098995




Registration number
NCT00098995
Ethics application status
Date submitted
8/12/2004
Date registered
9/12/2004
Date last updated
26/06/2013

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
CDR0000393978
Secondary ID [2] 0 0
PMCC-2004/354
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)

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
Key inclusion criteria
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
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
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
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
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
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
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

Summary
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
https://clinicaltrials.gov/show/NCT00098995
Trial related presentations / publications
Public notes

Contacts
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