Gefitinib and Sirolimus in Treating Patients With Recurrent or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer

  • Stage IIIB or IV disease

• Recurrent or refractory disease

  • Received ≥ 1 prior platinum-containing chemotherapy regimen
• Unidimensionally measurable disease that has not been irradiated
• No newly diagnosed untreated brain metastases or spinal cord compression
• Paraffin-embedded tumor tissue or slides available

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Adequate bone marrow function
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Adequate hepatic function
• No severe or uncontrolled hepatic disease

Renal

• Adequate renal function
• Creatinine ≤ 3.0 times upper limit of normal
• No severe or uncontrolled renal disease

Cardiovascular

• Adequate cardiac function
• No severe or uncontrolled cardiac disease
• No uncontrolled hyperlipidemia

Pulmonary

• No unstable or uncompensated respiratory disease

• No clinically active interstitial lung disease

  • Patients with chronic stable radiographic changes who are asymptomatic are eligible

Gastrointestinal

• Able to take oral medication
• No gastrointestinal condition (e.g., peptic ulcer disease) that would affect absorption

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No serious infection
• No known severe hypersensitivity to gefitinib or any of its excipients
• No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other severe or uncontrolled systemic disease
• No significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 14 days since prior biologic therapy
• No prior cetuximab, panitumumab, or bevacizumab

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• More than 3 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• Recovered from prior oncologic or other major surgery
• No prior gastrointestinal surgery affecting absorption
• No concurrent surgery, including ophthalmic surgery, during and for 1 week after study treatment

Other

• Recovered from all prior therapy
• More than 30 days since prior investigational agents

• No other prior HER1/epidermal growth factor receptor axis agents, including the following:

  • Gefitinib
  • Erlotinib
  • CI-1033
  • Lapatinib

• No other prior vascular endothelial growth factor axis agents, including the following:

  • ZD6474
  • Vatalanib

• No concurrent CYP3A4 inducers, including the following:

  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Phenobarbital
  • Barbiturates
  • Hypericum perforatum (St. John's wort)
• No other concurrent systemic treatment for the malignancy
• No concurrent bisphosphonates for symptomatic bone metastases
• No concurrent systemic retinoids