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

Sponsor:	Hospital Arnau de Vilanova
Information provided by:	Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:	NCT00908336

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Docetaxel and Erlotinib Drug: Erlotinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Hospital Arnau de Vilanova:

Primary Outcome Measures:

Percentage of patients without disease progression after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months. ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: 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. ] [ Designated as safety issue: No ]
Overall Response Rate [ Time Frame: The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months. ] [ Designated as safety issue: No ]
Disease Control Rate [ Time Frame: 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. ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment. ] [ Designated as safety issue: No ]
Safety profile [ Time Frame: Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Docetaxel and Erlotinib: Experimental Patients in the experimental arm will receive sequential treatment of intermittent erlotinib and docetaxel up to 4 cycles in the absence of disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment. After 4 cycles, participants will receive 150 mg of erlotinib per day until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.	Drug: Docetaxel 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
Erlotinib: Active Comparator Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.	Drug: Erlotinib 150 mg/day po daily

Arms

Assigned Interventions

Docetaxel and Erlotinib: Experimental

Patients in the experimental arm will receive sequential treatment of intermittent erlotinib and docetaxel up to 4 cycles in the absence of disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.

After 4 cycles, participants will receive 150 mg of erlotinib per day until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.

Drug: Docetaxel 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

Erlotinib: Active Comparator

Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.

Drug: Erlotinib

150 mg/day po daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908336

Contacts

Contact: Oscar Juan, Doctor	0034963868501	juan_osc@gva.es
Contact: Vicente Alberola, Doctor	0034649974055	alberola_vicara@gva.es

Locations

Spain
Hospital San Juan de Alicante	Recruiting
Alicante, Spain, 03550
Contact: Antonio López, Doctor 0034965938639 aljimenez73@hotmail.com
Principal Investigator: Antonio López, Doctor
Hospital Arnau de Vilanova	Recruiting
Valencia, Spain, 46015
Contact: Oscar Juan, Doctor 0034963868500 juan_osc@gva.es
Principal Investigator: Oscar Juan, Doctor
Hospital Universitario Dr. Peset	Recruiting
Valencia, Spain, 46017
Contact: José Muñoz, Doctor 0034961262300 munyoz_joslan@gva.es
Principal Investigator: José Muñoz, Doctor
Spain, Alicante
Hospital Clínica de Benidorm	Recruiting
Benidorm, Alicante, Spain, 03501
Contact: Gaspar Esquerdo, Doctor 0034965853850 gesquerdo@clinicabenidorm.com
Principal Investigator: Gaspar Esquerdo, Doctor
Hospital General de Elda	Not yet recruiting
Elda, Alicante, Spain, 03600
Contact: Sonia Maciá, Doctor 0034966989109 smacia@tiscali.es
Principal Investigator: Sonia Maciá, Doctor
Hospital Virgen de los Lirios	Recruiting
Alcoy, Alicante, Spain, 3804
Contact: Francisco Aparisi, Doctor 0034966528804 joseponcelorenzo@hotmail.com
Principal Investigator: Francisco Aparisi, Doctor
Spain, Castellón
Hospital Provincial de Castellón	Recruiting
Castellón de la Plana, Castellón, Spain, 12002
Contact: Alfreso Sánchez, Doctor 0034964354350 asanchezh@seom.org
Principal Investigator: Alfredo Sánchez, Doctor
Spain, Valencia
Hospital de Sagunto	Recruiting
Sagunto, Valencia, Spain, 46520
Contact: Vicente Giner, Doctor 0034962659405 vginermaco@hotmail.com
Principal Investigator: Vicente Giner, Doctor

Sponsors and Collaborators

Hospital Arnau de Vilanova

Investigators

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

More Information

No publications provided

Responsible Party:	ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA ( Vicente Alberola Candel )
Study ID Numbers:	ML25033
Study First Received:	May 21, 2009
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00908336 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Arnau de Vilanova:

Adenocarcinoma
Carcinoma, Non-Small Cell
Lung Neoplasms

Docetaxel
Erlotinib
Chemotherapy

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma

Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010