Trial record 1 of 1 for:    NCT00908336
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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 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

May 21, 2009
May 22, 2009
March 2009
August 2010   (final data collection date for primary outcome measure)
Percentage of patients without disease progression after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00908336 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • 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
  • Drug: Erlotinib
    150 mg/day po daily
  • 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.

    Intervention: Drug: Docetaxel and Erlotinib
  • 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.
    Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Oscar Juan, Doctor 0034963868501 juan_osc@gva.es
Contact: Vicente Alberola, Doctor 0034649974055 alberola_vicara@gva.es
Spain
 
NCT00908336
ML25033
No
Vicente Alberola Candel, ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA
Hospital Arnau de Vilanova
Not Provided
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
Hospital Arnau de Vilanova
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP