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 because the information has not been verified recently.
Verified May 2009 by Hospital Arnau de Vilanova.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:
NCT00908336
First received: May 21, 2009
Last updated: May 22, 2009
Last verified: May 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Virgen de los Lirios Recruiting
Alcoy, Alicante, Spain, 3804
Contact: Francisco Aparisi, Doctor    0034966528804    joseponcelorenzo@hotmail.com   
Principal Investigator: Francisco Aparisi, Doctor         
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 Provincial de Castellón Recruiting
Castellón de la Plana, Castellón, Spain, 12002
Contact: Alfreso Sánchez, Doctor    0034964354350    asanchezh@seom.org   
Principal Investigator: Alfredo Sánchez, Doctor         
Hospital de Sagunto Recruiting
Sagunto, Valencia, Spain, 46520
Contact: Vicente Giner, Doctor    0034962659405    vginermaco@hotmail.com   
Principal Investigator: Vicente Giner, Doctor         
Hospital San Juan de Alicante Recruiting
Alicante, Spain, 03550
Contact: Antonio López, Doctor    0034965938639    aljimenez73@hotmail.com   
Principal Investigator: Antonio López, Doctor         
Hospital Universitario Dr. Peset Recruiting
Valencia, Spain, 46017
Contact: José Muñoz, Doctor    0034961262300    munyoz_joslan@gva.es   
Principal Investigator: José Muñoz, Doctor         
Hospital Arnau de Vilanova Recruiting
Valencia, Spain, 46015
Contact: Oscar Juan, Doctor    0034963868500    juan_osc@gva.es   
Principal Investigator: Oscar Juan, 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: Vicente Alberola Candel, ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA
ClinicalTrials.gov Identifier: NCT00908336     History of Changes
Other Study ID Numbers: ML25033
Study First Received: May 21, 2009
Last Updated: May 22, 2009
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014