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

Sponsor
Hospital Arnau de Vilanova
Study ID
NCT00908336
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel and Erlotinib — DRUG
    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 — DRUG
    150 mg/day po daily

Study Details

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.

Key Dates

First listed
May 25, 2009
Start date
Mar 31, 2009
Status verified
May 2009
Primary completion
Aug 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of patients without disease progression after 6 months of treatment. [ Time Frame: 6 months ]

Central Contacts

Related Studies