Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098995
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2004-12-08
Brief Title:
Tirapazamine Cisplatin and Radiation Therapy in Treating Patients With Stage IB Stage II Stage III or Stage IVA Cervical Cancer
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Tirapazamine In Combination With Radiation And Weekly Cisplatin In Patients With Locally Advanced Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 squamous cell carcinoma adenocarcinoma or adenosquamous cell carcinoma of the cervix
Determine the safety and tolerability of this regimen in these patients
Secondary
Determine failure-free survival of patients treated with this regimen
Determine overall survival of patients treated with this regimen
Determine time to locoregional failure in patients treated with this regimen
Determine patterns of failure for the site of first failure in patients treated with this regimen
Determine the 12-week post-treatment complete response rate in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of tirapazamine
Patients receive tirapazamine IV over 2 hours on day 1 of weeks 1-5 and on days 3 and 5 of weeks 1 and 2 cohort 2 only OR days 3 and 5 of weeks 1-4 cohort 3 only Patients also receive cisplatin IV over 1 hour on day 1 of weeks 1-6 Patients concurrently undergo external beam radiotherapy once daily on days 1-5 for 5-55 weeks After completion of chemoradiotherapy patients undergo low-dose brachytherapy up to 2 implants within an 8-week period OR high-dose brachytherapy twice weekly for 5 treatments Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 10 patients are treated at the MTD
Patients are followed at 2 4 and 8 weeks at 3 and 6 months every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 3-22 patients will be accrued for this study
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 squamous cell carcinoma adenocarcinoma or adenosquamous cell carcinoma of the cervix
Determine the safety and tolerability of this regimen in these patients
Secondary
Determine failure-free survival of patients treated with this regimen
Determine overall survival of patients treated with this regimen
Determine time to locoregional failure in patients treated with this regimen
Determine patterns of failure for the site of first failure in patients treated with this regimen
Determine the 12-week post-treatment complete response rate in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of tirapazamine
Patients receive tirapazamine IV over 2 hours on day 1 of weeks 1-5 and on days 3 and 5 of weeks 1 and 2 cohort 2 only OR days 3 and 5 of weeks 1-4 cohort 3 only Patients also receive cisplatin IV over 1 hour on day 1 of weeks 1-6 Patients concurrently undergo external beam radiotherapy once daily on days 1-5 for 5-55 weeks After completion of chemoradiotherapy patients undergo low-dose brachytherapy up to 2 implants within an 8-week period OR high-dose brachytherapy twice weekly for 5 treatments Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 10 patients are treated at the MTD
Patients are followed at 2 4 and 8 weeks at 3 and 6 months every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 3-22 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5485 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000393978 | REGISTRY | None | None |