Clinical trial NCT00416650: Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official title: Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
bronchoalveolar cell lung cancer
recurrent non-small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride.

Secondary

* Assess the quality of life of patients treated with this regimen.
* Determine the duration of response and time to disease progression in patients treated with this regimen.
* Determine the median survival of patients treated with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)

  * Stage IIIB (malignant pleural or pericardial effusion) disease
  * Stage IV disease
  * Recurrent and/or medically inoperable disease
* Measurable or evaluable indicator lesions
* No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
* Life expectancy ≥ 8 weeks
* WBC ≥ 3,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.0 mg/dL
* AST ≤ 2 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No significant medical history or unstable medical condition, including any of the following:

  * Unstable systemic disease
  * Congestive heart failure
  * Recent myocardial infarction
  * Unstable angina
  * Active infection
  * Uncontrolled hypertension
* No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
* At least 3 weeks since prior chemotherapy
* No more than 1 prior chemotherapy regimen for NSCLC
* No prior systemic cytotoxic chemotherapy for other malignant diseases
* No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab \[Herceptin®\], or gefitinib)
* No concurrent radiotherapy or chemotherapy

Primary outcomes:
measure: Major objective response rate (complete response and partial response)
timeFrame: At 4 weeks and then every 8 weeks
Secondary outcomes:
measure: Worst grade toxicity
timeFrame: weekly for 4 weeks, then every 8 weeks to discontinuation of drug
measure: Quality of life as measured by the Lung Cancer Symptom Scale for patients
timeFrame: baseline, every week for 5 weeks, and then every 4 weeks
measure: Survival
timeFrame: from study entry to date of death or last date known alive
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: William Pao, MD
role: PRINCIPAL_INVESTIGATOR
References: