Status:
TERMINATED
Pemetrexed Disodium and Cisplatin Before or After Surgery in Treating Patients With Stage IB or Stage II Non-Small Cell Lung Cancer That Can be Removed by Surgery
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividin...
Detailed Description
OBJECTIVES: Primary * Compare the tolerability (in terms of drug delivery and toxicity) of neoadjuvant vs adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with resectab...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Stage IB or II disease
- Resectable disease
- At least 1 measurable lesion
- No mediastinal involvement by mediastinoscopy and/or positron emission tomography with fludeoxyglucose F 18 scan
- No evidence of metastatic disease
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 10 g/dL
- Creatinine clearance ≥ 60 mL/min
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3.0 times ULN
- AST and ALT ≤ 3.0 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignant disease, except for the following:
- Basocellular carcinoma of the skin
- Adequately treated carcinoma in situ of the cervix
- Low-grade prostate cancer
- Other cancer for which the patient has been disease-free for ≥ 5 years
- No congestive heart failure or angina pectoris unless medically controlled
- No myocardial infarction within the past 6 months
- No uncontrolled hypertension or arrhythmia
- No active uncontrolled infection requiring antibiotics
- No illness or medical condition that would preclude study participation
- No pre-existing motor or sensory neurotoxicity ≥ grade 2
- PRIOR CONCURRENT THERAPY:
- No prior surgery for NSCLC
- No prior or other concurrent chemotherapy for NSCLC
- No prior or concurrent radiotherapy for NSCLC
- No concurrent immunotherapy
- No concurrent targeted agents
- No concurrent hormonal cancer therapy
- No concurrent routine colony-stimulating factor (e.g., prophylactic filgrastim \[G-CSF\])
- No aspirin or nonsteroidal anti-inflammatory drugs within 5 days before or after chemotherapy
- No other concurrent experimental treatments
- No other concurrent anticancer treatments
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00389688
Start Date
August 1 2006
Last Update
July 18 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650