Laboratory Test in Predicting Response to Erlotinib in Patients With Relapsed Metastatic or Unresectable Non-Small Cell Lung Cancer That Did Not Respond to Previous Treatment

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how well patients will respond to treatment.

PURPOSE: This phase II trial is studying how well a laboratory test predicts response to erlotinib in patients with metastatic or unresectable non-small cell lung cancer that did not respond to previous treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic or unresectable non-small cell lung cancer

• Relapsed disease

• Failed ≥ 1 prior chemotherapy regimen

• Measurable disease

• Tumor must be accessible to fine-needle aspiration

• No uncontrolled brain metastases

• Patients with brain metastases must have stable neurologic status after local therapy (surgery or radiotherapy) for ≥ 4 weeks and no neurologic dysfunction that would preclude evaluation of neurologic and other adverse events

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• Life expectancy > 12 weeks

• WBC > 3,000/mm³

• Absolute neutrophil count > 1,500/mm³

• Platelet count > 100,000/mm³

• Bilirubin normal

• PT and activated PTT normal

• Creatinine normal OR creatinine clearance > 60 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled intercurrent illness, including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situation that would preclude study compliance

• No significant ophthalmologic abnormalities*, including any of the following:

• Severe dry eye syndrome

• Keratoconjunctivitis sicca

• Sjögren's syndrome

• Severe exposure keratopathy

• Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)

• No serious, nonhealing wound, ulcer, or bone fracture

• No significant traumatic injury within the past 14 days NOTE: *Patients with mild forms of any of the above ophthalmologic abnormalities, an asymptomatic history, or a normal ophthalmologic examination allowed at the discretion of the investigator. Patients with treatable conditions (e.g., infectious keratitis/conjunctivitis or allergic conjunctivitis) allowed after treatment or resolution of the condition.

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior small molecule inhibitors of epidermal growth factor receptor, including erlotinib hydrochloride or gefitinib

• At least 4 weeks since prior anticancer therapy, including chemotherapy, radiotherapy, biologic therapy, or other investigational therapy (6 weeks for nitrosoureas or mitomycin C)

• More than 14 days since prior major surgery or open biopsy and recovered

• At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:

• Itraconazole

• Herbal extracts and tinctures, including any of the following:

• Hydrastis canadensis (goldenseal)

• Uncaria tomentosa (cat's claw)

• Echinacea angustifolia roots

• Trifolium pratense (wild cherry)

• Chamomile

• Licorice root

• Dillapiol

• Naringenin

• No concurrent inducers of CYP3A4, including any of the following:

• Phenytoin

• Carbamazepine

• Rifampin

• Barbiturates

• Hypericum perforatum (St. John's wort)

• No concurrent chemotherapy

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent radiotherapy, including palliative radiotherapy

• No concurrent therapeutic anticoagulation

• No other concurrent anticancer agents or therapies