Status:
COMPLETED
Radiation Therapy Combined With Either Gefitinib or Temozolomide in Pats With NSCLC and Brain Metastases
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherap...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of whole-brain radiotherapy combined with either gefitinib or temozolomide, in terms of overall survival, in patients with non-small cell lung cancer and b...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer AND newly diagnosed brain metastases meeting 1 of the following criteria:
- Multiple brain metastases
- Single brain metastasis not amenable to potentially curative treatment
- No advanced extracranial disease severely compromising vital functions and performance
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Hemoglobin \> 10 g/dL
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of documented bone metastases)
- No unstable or uncompensated hepatic disease that would preclude study participation
- Renal
- Creatinine clearance ≥ 40 mL/min
- No unstable or uncompensated renal disease that would preclude study participation
- Cardiovascular
- No myocardial infarction within the past 3 months
- No unstable or uncompensated cardiac disease that would preclude study participation
- Pulmonary
- No clinically active interstitial lung disease
- Patients with chronic stable radiographic changes who are asymptomatic eligible
- No other unstable or uncompensated respiratory disease that would preclude study participation
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- No nausea, vomiting, inability to swallow whole tablets/capsules, or malabsorption syndrome that would preclude oral medication ingestion or absorption
- No psychiatric disorder that would preclude giving informed consent or study compliance
- No active infection
- No uncontrolled diabetes mellitus
- No other medical condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior temozolomide
- Endocrine therapy
- Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 4 days before study entry
- Radiotherapy
- No prior brain irradiation
- Surgery
- Not specified
- Other
- No prior gefitinib or erlotinib
- More than 30 days since prior investigational clinical trial participation
- No other concurrent experimental drugs
- No other concurrent anticancer therapy
- No concurrent treatment with any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Barbiturates
- Hypericum perforatum (St. John's wort)
- Other enzyme-inducing anti-epileptic drugs or tuberculostatic treatments
- Any drug that contraindicates administration with study drugs
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00238251
Start Date
May 1 2005
End Date
November 1 2010
Last Update
June 5 2012
Active Locations (3)
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1
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
2
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
3
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011