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

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Oct 18, 2006

Keywords

ClinConnect Summary

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 resectable stage IB or II non-small cell lung cancer.

Secondary

* Determine the overall toxicity of this regimen in these patients.
* Determine the progression-free and overall survival of patients treated with this regimen.
* Determine the overall clinical response rate, pathologic complete response, and resectability rate in patients treated with neoadjuvant chemotherapy.
* Determine the surgical m...

Gender

ALL

Eligibility criteria

• 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