Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Docetaxel and Erlotinib (Drug); Erlotinib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Hospital Arnau de Vilanova

Official(s) and/or principal investigator(s):
Oscar Juan, Doctor, Principal Investigator, Affiliation: Hospital Arnau de Vilanova de Valencia
Gaspar Esquerdo, Doctor, Principal Investigator, Affiliation: Hospital Clínica de Benidorm
Alfredo Sánchez, Doctor, Principal Investigator, Affiliation: Hospital Provincial de Castellón
Sonia Maciá, Doctor, Principal Investigator, Affiliation: Hospital General de Elda
Vicente Giner, Doctor, Principal Investigator, Affiliation: Hospital de Sagunto
José Muñoz, Doctor, Principal Investigator, Affiliation: H. Universitario Dr. Peset
Antonio López, Doctor, Principal Investigator, Affiliation: Hospital San Juan de Alicante
Francisco Aparisi, Doctor, Principal Investigator, Affiliation: Hospital Virgen de los Lirios

Overall contact:
Oscar Juan, Doctor, Phone: 0034963868501, Email: juan_osc@gva.es

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.

Official title: Phase II, Multicenter, Randomized, Open Label Study of a Sequential Treatment of Intermittent Erlotinib and Docetaxel Versus Erlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer After Failure of a Prior Chemotherapy Regimen

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percentage of patients without disease progression after 6 months of treatment.

Secondary outcome:

Progression-free survival

Duration of Response

Overall Response Rate

Disease Control Rate

Overall survival

Safety profile

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Oscar Juan, Doctor, Phone: 0034963868501, Email: juan_osc@gva.es

Hospital San Juan de Alicante, Alicante 03550, Spain; Recruiting
Antonio López, Doctor, Phone: 0034965938639, Email: aljimenez73@hotmail.com
Antonio López, Doctor, Principal Investigator

Hospital Arnau de Vilanova, Valencia 46015, Spain; Recruiting
Oscar Juan, Doctor, Phone: 0034963868500, Email: juan_osc@gva.es
Oscar Juan, Doctor, Principal Investigator

Hospital Universitario Dr. Peset, Valencia 46017, Spain; Recruiting
José Muñoz, Doctor, Phone: 0034961262300, Email: munyoz_joslan@gva.es
José Muñoz, Doctor, Principal Investigator

Hospital Clínica de Benidorm, Benidorm, Alicante 03501, Spain; Recruiting
Gaspar Esquerdo, Doctor, Phone: 0034965853850, Email: gesquerdo@clinicabenidorm.com
Gaspar Esquerdo, Doctor, Principal Investigator

Hospital General de Elda, Elda, Alicante 03600, Spain; Not yet recruiting
Sonia Maciá, Doctor, Phone: 0034966989109, Email: smacia@tiscali.es
Sonia Maciá, Doctor, Principal Investigator

Hospital Virgen de los Lirios, Alcoy, Alicante 3804, Spain; Recruiting
Francisco Aparisi, Doctor, Phone: 0034966528804, Email: joseponcelorenzo@hotmail.com
Francisco Aparisi, Doctor, Principal Investigator

Hospital Provincial de Castellón, Castellón de la Plana, Castellón 12002, Spain; Recruiting
Alfreso Sánchez, Doctor, Phone: 0034964354350, Email: asanchezh@seom.org
Alfredo Sánchez, Doctor, Principal Investigator

Hospital de Sagunto, Sagunto, Valencia 46520, Spain; Recruiting
Vicente Giner, Doctor, Phone: 0034962659405, Email: vginermaco@hotmail.com
Vicente Giner, Doctor, Principal Investigator

Starting date: March 2009
Ending date: December 2010
Last updated: May 22, 2009