Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer
NCT ID: NCT00428194
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2007-01-31
2008-03-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
Detailed Description
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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 of the cervix.
Secondary
* Determine the toxicity profile of this regimen.
OUTLINE: This is a multicenter, open-label, dose-escalation study of erlotinib hydrochloride.
Patients receive oral erlotinib hydrochloride once daily on days 1-35 and cisplatin IV on days 1, 8, 15, 22, and 29. Patients also undergo radiotherapy daily, 5 days a week, for approximately 5 weeks concurrently with chemotherapy.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 6 weeks.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
Erlotinib 100 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation
cisplatin
40 mg/m\^2 every 7 days during radiation
erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.
radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Cohort 2
Erlotinib 125 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation
cisplatin
40 mg/m\^2 every 7 days during radiation
erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.
radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Cohort 3
Erlotinib 150 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation
cisplatin
40 mg/m\^2 every 7 days during radiation
erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.
radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Interventions
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cisplatin
40 mg/m\^2 every 7 days during radiation
erlotinib hydrochloride
Erlotinib escalating dose per schedule - 100, 125 and 150 mg/m\^2 by mouth once a day beginning day 1.
radiation therapy
standard (fixed) doses of pelvic irradiation (as determined by their radiation oncologist)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Levi S. Downs, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-0604M84827
Identifier Type: OTHER
Identifier Source: secondary_id
2006LS019
Identifier Type: -
Identifier Source: org_study_id