Status:
WITHDRAWN
Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of erlotinib hydrochloride when administered with cisplatin and pelvic radiotherapy in patients with stage IB-IVA squamous cell carcinoma o...
Eligibility Criteria
Inclusion
- Diagnosis of squamous cell carcinoma of the cervix
- Stage IB-IVA disease
- Scheduled to undergo standard radiotherapy and receive weekly cisplatin
- ECOG performance status 0-2
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment
- Must be able to take oral medication
Exclusion
- Malabsorption syndrome
- Serious underlying medical condition that would impair the ability of patient to receive treatment
- Known hypersensitivity to erlotinib hydrochloride
- Psychological, familial, sociological, or geographical conditions that would preclude study compliance
- Less than 21 days since prior nonapproved or investigational drugs
- Prior chemotherapy
- Prior radiotherapy
- Prior anti-epidermal growth factor receptor treatment
- Prior gastrointestinal surgery that limits absorption (i.e., requiring total parenteral nutrition)
- Concurrent use of any of the following agents and therapies:
- Other antineoplastic or antitumor agents
- Other chemotherapy
- Other investigational agents
- Radiotherapy
- Immunotherapy
- Anticancer hormonal therapy
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00428194
Start Date
January 1 2007
End Date
March 1 2008
Last Update
November 29 2017
Active Locations (1)
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1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455