A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00510250|
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : July 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Cervix||Drug: Sorafenib Drug: Cisplatin Procedure: Radiation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||July 2015|
|Experimental: Cisplatin and Radiation in Combination with 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
40mg/m2 administered weekly via IV, with Radiation
Administered for 30-40 days.Combination of external beam radiotherapy followed by intra-cavitary brachytherapy.
- Determine the biologic activity of sorafenib in cervix cancer. [ Time Frame: Not Determined ]
- Determine the acute and late toxicity, and effect of sorafenib in combination with radiation and chemotherapy on the disease-free survival of patients with high-risk cervix cancer. [ Time Frame: Not Determined ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510250
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza, MD FRCP||Princess Margaret Hospital, Canada|
|Principal Investigator:||Michael Milosevic, MD FRCPC||Princess Margaret Hospital, Canada|