Non-Small Cell Lung Cancer
Conditions
Keywords
Adenocarcinoma, Carcinoma, Non-Small Cell, Lung Neoplasms, Docetaxel, Erlotinib, Chemotherapy
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 preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy. This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.
Interventions
DRUGDocetaxel and Erlotinib
Docetaxel (Taxotere®) 75 mg/m2 iv first day of each 21-day cycle. Erlotinib (Tarceva®) 150 mg po days 2-16 of each 21-day cycle. Total: 4 cycles in the absence of disease progression
DRUGErlotinib
150 mg/day po daily
Sponsors
Hospital Arnau de Vilanova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients without disease progression after 6 months of treatment. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response | The time from the first complete response or partial response until objective tumor progression or death due to progression disease. Tumour progression will be assessed every 2 months. |
| Overall Response Rate | The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months. |
| Progression-free survival | Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months. |
| Overall survival | Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment. |
| Safety profile | Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks. |
| Disease Control Rate | The proportion of patients without tumor size increase (complete response, partial response or stable disease following RECIST criteria). Response wil be assessed every 2 months. |
Countries
Spain
Contacts
Primary ContactOscar Juan, Doctor
Backup ContactVicente Alberola, Doctor
Outcome results
None listed