Status:
WITHDRAWN
Gefitinib and Sirolimus in Treating Patients With Recurrent or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of sirolimus when combined with gefitinib in patients with recurrent or refractory stage IIIB or IV non-small cell lung cancer. Secondary ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00098462
Start Date
October 1 2004
Last Update
October 4 2012
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