EUCTR2005-003814-14-ES
Active, not recruiting
Not Applicable
Pharmacodynamic study of Erlotinib (Tarceva) in patients with mestastatic or locally advanced Epidermoid carcinoma of the head and neck
nidad Integral de Investigación en Oncología, S.L.0 sites49 target enrollmentStarted: January 17, 2006Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- nidad Integral de Investigación en Oncología, S.L.
- Enrollment
- 49
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Aceptation of the patiens to participate in the trial with their written consent prior to the commencement of the trial\-related procedures.
- •Patients with a histological proven diagnosis of cancer of head and neck incurable with other treatments of cirugy and radiotherapy.The nor distinghised carcinomas and not queratinizados as linfoepiteliomas in aereas of cancer of parotida glándula except: Patients with cancer de squamous cell WHO tipo I of nasofaringe.
- •Ages 18\-70 years
- •Life\-expectancy \>12 weeks
- •Measurable disease,RECIST criteria
- •Fulfifment of the treatment and the patiens must be geographically accessible for treatment and follow\-up.
- •If the patients have received a prior treatment:
- •Chemotherapy: the patients musn,t have received more of 2 cycles of chemotherapy to the the treatment of the local disease and/or metastasic.The patients that have received the induction o chemoradiotherapy with a healing intention to local disease can participate in the trial if they have not received more of 2 cycles of chemotherapy to the recurrent disease. That treatment must have completed at least 14 days prior to the commencement of the trial.Every patients must have recovered of the toxic sever effects in relation with the prior treatment.The prior treatment of diana treatment such as inhibidores of tirosin quinasa and monoclonales antibodys.
- •Radiotherapy:prior radiotherapy treatment is allowed if the patients
- •have recovered of the toxic sever effects in relation the treatment before to start the trial.It must have been passed 14 days since the end of the radiotherapy treatment. The disease progression in a previous irradiated area must be demonstrated by byopsia or tomografic image.
Exclusion Criteria
- •Not writen informed consent.
- •Another medical treatment with experimental drugs or another simultaneous chemotherapeutic drugs during the study.
- •Patients with different histologic diagnosis of epidermoid carcinoma.
- •Another previous neoplasia, except basal cell carcinoma or squamous carcinoma of skin, previous treated; resecate cervix carcinoma.
- •Pregnant or lactancy women.
- •Patiens with active infection
- •Serious concomitant disease or patients with life expectancy smallest than their neoplasic disease.
- •Serious psychiatric disease not controled.
- •Patients unable to take oral medication or patients whose take intravenous food or patients with an intervention which interferes to the apsortion or patients with active peptic ulcer.
- •Follow\-up not possible.
Investigators
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