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

NCT00510250 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-07-27

No results posted yet for this study

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.

Conditions

  • Cancer of the Cervix

Interventions

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Amit Oza, MD FRCP · Princess Margaret Hospital, Canada

  • Michael Milosevic, MD FRCPC · Princess Margaret Hospital, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-09-30
Completion
2015-07-31

Countries

  • Canada

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00510250 on ClinicalTrials.gov