Status:
UNKNOWN
Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen
Lead Sponsor:
Hospital Arnau de Vilanova
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population. However, several ...
Eligibility Criteria
Inclusion
- Written informed consent.
- Age \>= 18 years.
- Histologically or cytologically documented inoperable, locally advanced (stage IIIb with malignant pleural or pericardial effusion) or metastatic (Stage IV) NSCLC.
- Patients who have failed only one prior chemotherapy to treat the advanced disease and candidates to receive a second line treatment.
- ECOG PS 0-2.
- Adequate hematological function: hemoglobin =\> 9 g/dl; neutrophils count =\> 1.5 x 10(9)/l; platelet count =\> 100 x 10(9)/l.
- Adequate liver function: Bilirubin \<= 1,5 x ULN; AST and ALT \<= x 3 ULN when no hepatic metastases or \<=5 x ULN if hepatic metastases; Alkaline phosphatase \<=5 x UNL except that there is hepatic metastases.
- Adequate renal function: Calculated creatinine clearance =\> 40 mL/min (Cockroft y Gault) or serum creatinine \<= 1.5 x ULN .
- Patient able to meet the requirements of the study and accessible for correct follow-up.
- Oral swallowing capability.
Exclusion
- Previous treated with more than one chemotherapeutic treatment for NSCLC
- Concomitant treatment with another drug under investigation.
- Pregnancy or lactation. Fertile women must provide a negative result of pregnancy test (in serum or urine) within 7 days prior to study treatment start. In addition, they must use an effective method of contraception (oral contraceptives, intrauterine device, barrier methods of contraception, together with spermicidal jelly or surgical sterilization) during the study.
- Evidence of other disease, metabolic or neurological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
- Contraindication for the use of erlotinib or docetaxel.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00908336
Start Date
March 1 2009
End Date
December 1 2010
Last Update
May 25 2009
Active Locations (8)
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1
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain, 3804
2
Hospital San Juan de Alicante
Alicante, Alicante, Spain, 03550
3
Hospital Clínica de Benidorm
Benidorm, Alicante, Spain, 03501
4
Hospital General de Elda
Elda, Alicante, Spain, 03600