Pharmacodynamic study of Erlotinib (Tarceva) in patients with mestastatic or locally advanced Epidermoid carcinoma of the head and neck

• Conditions: Mestastatic or locally advanced Epidermoid carcinoma of the head and neck

• Registration Number: EUCTR2005-003814-14-ES
• Lead Sponsor: nidad Integral de Investigación en Oncología, S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 49

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.
ECOG 0-2
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.
previous surgery: it is possible it the injury has healed and the surgery has been performed 14 days before the start of the trial
TArget lesion >=20mm (or >=10mm CT spiral). If the area is a previous irradiated area it must be documented the disease progression or to be present a residual cancer demonstrated by byopsia
Optima organic function according to: a)adequate medular function, ANC>1.5x109L, platelets>100x109L and hemoglobin>9g/dl
b)adequate hepatic and renal function
negative pregnancy test
Good cardiovascular function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
Symptomatic unstable metastasic brain, not controled with esteroids, life potential menace or with radiotherapy in the 14 days before the beginning of the study.
Any disease, metabolic malfunction, abnormal physical exploration or analytic information who suggest an inconvenient condition for the administration of the trial medication that might affect the study results or increase the risk of patient treatment.
Frequent vomits or medical disease who interferes to oral ingestion of medicaments.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified