NCT00510250

A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of the Cervix

Interventions

Type	Name	Description
DRUG	Sorafenib	200mg PO BID x 7 days prior to Radiation and Cisplatin for Low-Risk Patients or 200mg PO BID x 7 days prior to, and 35 days during Radiation and Cisplatin for High-Risk Patients
DRUG	Cisplatin	40mg/m2 administered weekly via IV, with Radiation
PROCEDURE	Radiation	Administered for 30-40 days.Combination of external beam radiotherapy followed by intra-cavitary brachytherapy.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-09-01
• Completion: 2015-07-01
• First posted: 2007-08-01
• Last updated: 2015-07-27

Locations

1 site across 1 country: Canada