Status:
COMPLETED
NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer
Lead Sponsor:
NovoCure Ltd.
Conditions:
Non-small Cell Lung Cancer
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
An open-label phase I-II trial will be performed in 42 patients with pretreated locally advanced non-small cell lung cancer. The trial is designed to estimate the efficacy and to determine safety of N...
Detailed Description
The trial will be conducted in two stages. Fourteen patients will be recruited to a phase I stage of the trial. After all 14 patients have received 3 courses of Alimta (9 weeks of NovoTTF-100L treatme...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IV or IIIB with malignant pleural effusion, also locally advanced NSCLC not otherwise amenable to local treatment (surgery or radiotherapy)
- One line of prior chemotherapy
- Measurable disease
- Greater or equal to 18 years
- Life expectancy of at least 12 weeks
- ECOG performance status 0-2
- Laboratory requirements at entry:
- Blood cell counts:
- Absolute neutrophils ≥ 1.0 x 109/L
- Platelets ≥100 x 109/L
- Hemoglobin ≥ 10 g/dl
- Renal function:
- Creatinine clearance ≥ 45 mL/min
- Hepatic functions:
- ASAT and ALAT ≤ 3 x UNL
- Alkaline phosphatase ≤ 5 x UNL
- Signed informed consent prior to start protocol specific requirements
- Pregnancy test (β-HCG) must be negative (needed only for women of childbearing potential).
Exclusion
- Known brain metastases or meningeal carcinomatosis
- Other serious concomitant illness of medical conditions:
- Congestive heart failure or angina pectoris except if it is medically controlled.
- Previous history of myocardial infarction within 1 year from study entry.
- Uncontrolled hypertension or arrhythmias
- Implanted pacemaker, defibrillator or deep brain stimulation device
- History of significant neurologic or psychiatric disorders including dementia or seizures
- Active infection requiring iv antibiotics
- Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy
- Concurrent treatment with other experimental drugs
- Participation in clinical trials with other experimental agents within 30 days of study entry
- Psychological, familial, sociological or geographical conditions which don't permit medical follow-up and compliance with the study protocol
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00749346
Start Date
May 1 2008
End Date
July 1 2011
Last Update
September 27 2011
Active Locations (4)
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1
CCRC
Basel, Switzerland
2
Kantonspital Graubunden
Chur, Switzerland
3
Kantonspital Fribourg
Fribourg, Switzerland
4
Kantonspital Winterthur
Winterthur, Switzerland