Trial Title:
Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen
NCT ID:
NCT00908336
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Erlotinib Hydrochloride
Conditions: Keywords:
Adenocarcinoma
Carcinoma, Non-Small Cell
Lung Neoplasms
Docetaxel
Erlotinib
Chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel and Erlotinib
Description:
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
Arm group label:
Docetaxel and Erlotinib
Intervention type:
Drug
Intervention name:
Erlotinib
Description:
150 mg/day po daily
Arm group label:
Erlotinib
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Virgen de los Lirios
Address:
City:
Alcoy
Zip:
3804
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Francisco Aparisi, Doctor
Phone:
0034966528804
Email:
joseponcelorenzo@hotmail.com
Investigator:
Last name:
Francisco Aparisi, Doctor
Email:
Principal Investigator
Facility:
Name:
Hospital Clínica de Benidorm
Address:
City:
Benidorm
Zip:
03501
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Gaspar Esquerdo, Doctor
Phone:
0034965853850
Email:
gesquerdo@clinicabenidorm.com
Investigator:
Last name:
Gaspar Esquerdo, Doctor
Email:
Principal Investigator
Facility:
Name:
Hospital General de Elda
Address:
City:
Elda
Zip:
03600
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Sonia Maciá, Doctor
Phone:
0034966989109
Email:
smacia@tiscali.es
Investigator:
Last name:
Sonia Maciá, Doctor
Email:
Principal Investigator
Facility:
Name:
Hospital Provincial de Castellón
Address:
City:
Castellón de la Plana
Zip:
12002
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alfreso Sánchez, Doctor
Phone:
0034964354350
Email:
asanchezh@seom.org
Investigator:
Last name:
Alfredo Sánchez, Doctor
Email:
Principal Investigator
Facility:
Name:
Hospital de Sagunto
Address:
City:
Sagunto
Zip:
46520
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Vicente Giner, Doctor
Phone:
0034962659405
Email:
vginermaco@hotmail.com
Investigator:
Last name:
Vicente Giner, Doctor
Email:
Principal Investigator
Facility:
Name:
Hospital San Juan de Alicante
Address:
City:
Alicante
Zip:
03550
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Antonio López, Doctor
Phone:
0034965938639
Email:
aljimenez73@hotmail.com
Investigator:
Last name:
Antonio López, Doctor
Email:
Principal Investigator
Facility:
Name:
Hospital Arnau de Vilanova
Address:
City:
Valencia
Zip:
46015
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Oscar Juan, Doctor
Phone:
0034963868500
Email:
juan_osc@gva.es
Investigator:
Last name:
Oscar Juan, Doctor
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Dr. Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Status:
Recruiting
Contact:
Last name:
José Muñoz, Doctor
Phone:
0034961262300
Email:
munyoz_joslan@gva.es
Investigator:
Last name:
José Muñoz, Doctor
Email:
Principal Investigator
Start date:
March 2009
Completion date:
December 2010
Lead sponsor:
Agency:
Hospital Arnau de Vilanova
Agency class:
Other
Source:
Hospital Arnau de Vilanova
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00908336
