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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Hospital Arnau de Vilanova.
Recruitment status was:  Recruiting
Information provided by:
Hospital Arnau de Vilanova Identifier:
First received: May 21, 2009
Last updated: May 22, 2009
Last verified: May 2009

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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 ]

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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • Overall survival [ Time Frame: Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment. ]
  • Safety profile [ Time Frame: Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks. ]

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
Experimental: Docetaxel and Erlotinib

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
Active Comparator: Erlotinib
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00908336

Hospital Virgen de los Lirios
Alcoy, Alicante, Spain, 3804
Hospital Clínica de Benidorm
Benidorm, Alicante, Spain, 03501
Hospital General de Elda
Elda, Alicante, Spain, 03600
Hospital Provincial de Castellón
Castellón de la Plana, Castellón, Spain, 12002
Hospital de Sagunto
Sagunto, Valencia, Spain, 46520
Hospital San Juan de Alicante
Alicante, Spain, 03550
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Hospital Arnau de Vilanova
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

Responsible Party: Vicente Alberola Candel, ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA Identifier: NCT00908336     History of Changes
Other Study ID Numbers: ML25033 
Study First Received: May 21, 2009
Last Updated: May 22, 2009

Keywords provided by Hospital Arnau de Vilanova:
Carcinoma, Non-Small Cell
Lung Neoplasms

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors processed this record on February 17, 2017