Clinical trial NCT00275132: Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official title: A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: Roche Pharma AG
First posted: 2006-01-11
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed description: OBJECTIVES:

Primary

* Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.

Secondary

* Compare progression-free survival and response rate.
* Compare toxicity.
* Compare the quality of life.
* Compare cost-effectiveness.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral erlotinib once daily for up to 24 months.
* Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer

  * Advanced disease (stage IIIB or IV)
  * Diagnosis within 62 days prior to randomization
* Not suitable for first-line chemotherapy, as defined by the following criteria\*:

  * ECOG performance status 2-3
  * ECOG performance status 0-1 AND creatinine clearance \< 60 mL/min
* NOTE: \*These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis
* No symptomatic brain metastases

PATIENT CHARACTERISTICS:

* Estimated life expectancy of at least 8 weeks
* Able to take oral medication
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe uncontrolled infection
* No unstable angina
* No myocardial infarction within the past month
* No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
* No acute renal failure
* Bilirubin \< 2 times upper limit of normal (ULN)
* Transaminases \< 2 times ULN (5 times ULN if liver metastases are present)
* Creatinine \< 5 times ULN
* No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications
* No other prior or current malignant disease likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)
* No prior palliative radiotherapy

  * Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks
* No concurrent cyclooxygenase-2 inhibitors

Primary outcomes:
measure: Overall survival
timeFrame: between date of randomisation and date of death from any cause
Secondary outcomes:
measure: Progression free survival
timeFrame: from the date of randomisation to the date of first clinical evidence of progressive disease, or death.
measure: Adverse events/Toxicity
timeFrame: during and for 28 days following Tarceva/placebo treatment
measure: Quality of life
timeFrame: between randomisation and 8 weeks.
measure: Cost-effectiveness
timeFrame: from date of randomisation to death
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Lung Cancer Group
state: England
Study officials:
affiliation: University College London Hospitals
name: Siow M Lee, MD, PhD, FRCP
role: STUDY_CHAIR
References: