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
Last Updated: 2009-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2009-03-31
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.
Erlotinib
150 mg/day po daily
Interventions
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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
150 mg/day po daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital Arnau de Vilanova
OTHER
Responsible Party
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ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA
Principal Investigators
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Oscar Juan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau de Vilanova de Valencia
Gaspar Esquerdo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínica de Benidorm
Alfredo Sánchez, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Provincial de Castellón
Sonia Maciá, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Elda
Vicente Giner, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital de Sagunto
José Muñoz, Doctor
Role: PRINCIPAL_INVESTIGATOR
H. Universitario Dr. Peset
Antonio López, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital San Juan de Alicante
Francisco Aparisi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Virgen de los Lirios
Locations
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Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital San Juan de Alicante
Alicante, Alicante, Spain
Hospital Clínica de Benidorm
Benidorm, Alicante, Spain
Hospital General de Elda
Elda, Alicante, Spain
Hospital Provincial de Castellón
Castellon, Castellón, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ML25033
Identifier Type: -
Identifier Source: org_study_id
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