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Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Adenocarcinoma, Carcinoma, Non-Small Cell, Lung Neoplasms, Docetaxel, Erlotinib, Chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel and Erlotinib
Type: Drug
Name: Erlotinib
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
- 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.
Locations
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital Clínica de Benidorm
Status: Recruiting
Contact: Francisco Aparisi, Doctor - 0034966528804 - joseponcelorenzo@hotmail.com
Benidorm, Alicante, Spain
Hospital General de Elda
Status: Recruiting
Contact: Gaspar Esquerdo, Doctor - 0034965853850 - gesquerdo@clinicabenidorm.com
Elda, Alicante, Spain
Hospital Provincial de Castellón
Status: Not yet recruiting
Contact: Sonia Maciá, Doctor - 0034966989109 - smacia@tiscali.es
Castellón de la Plana, Castellón, Spain
Hospital de Sagunto
Status: Recruiting
Contact: Alfreso Sánchez, Doctor - 0034964354350 - asanchezh@seom.org
Sagunto, Valencia, Spain
Hospital San Juan de Alicante
Status: Recruiting
Contact: Vicente Giner, Doctor - 0034962659405 - vginermaco@hotmail.com
Alicante, Spain
Hospital Arnau de Vilanova
Status: Recruiting
Contact: Antonio López, Doctor - 0034965938639 - aljimenez73@hotmail.com
Valencia, Spain
Hospital Universitario Dr. Peset
Status: Recruiting
Contact: Oscar Juan, Doctor - 0034963868500 - juan_osc@gva.es
Valencia, Spain
Status: Recruiting
Contact: José Muñoz, Doctor - 0034961262300 - munyoz_joslan@gva.es
Start Date
March 2009
Completion Date
December 2010
Sponsors
Hospital Arnau de Vilanova
Source
Hospital Arnau de Vilanova
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page