Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT00510250
Status:
COMPLETED
Last Update Posted:
2015-07-27
First Post:
2007-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a multi-institution, single-arm, open-label, phase I/II trial. Eligible patients will have pathologically-proven T1b-3b, N0/1, M0 epithelial carcinoma of the cervix. We hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have anti-tumor activity in patients with cervical cancer. Sorafenib has not previously been combined with conventional RT-CT to treat cervix cancer.
Detailed Description:
During the phase I component of the study, low risk patients (tumor size ≤5 cm and radiographically node negative) will receive sorafenib alone in escalating doses for at least 1 week prior to the start of conventional treatment with radiotherapy and chemotherapy (RT-CT). High risk patients (tumor \> 5 cm or node positive) will receive sorafenib alone in escalating dose for at least 1 week prior to the start of RT-CT, as well as concurrently with RT-CT. Cohorts of 3 patients per dose level are planned. If 1/3 patients encounters a dose-limiting toxicity (DLT), then that cohort will be expanded to 6 patients. If \>2/3 of patients encounter a DLT, then that dose level will be declared as the maximum tolerated dose (MTD). An additional 3 patients will be entered into the dose level one below the MTD. The recommended phase II dose (RPTD) is defined as the dose level with \< 1/6 patients with DLT.
For the phase II component, all patients will receive sorafenib at the RPTD for at least 1 week prior to, and concurrent with, RT-CT.
For the phase II component, all patients will receive sorafenib at the RPTD for at least 1 week prior to, and concurrent with, RT-CT.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Bayer Protocol# 12138 | None | None | View |