Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Lung Cancer
Trial Information
Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
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 morbidity and mortality of patients treated with these regimens.
- Determine the fraction of patients in the adjuvant arm that receives chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to institution, histological subtype (squamous vs nonsquamous) and clinical stage
(IB vs II). Patients are randomized to 1 of 2 treatment arms.
- Arm I (neoadjuvant chemotherapy): Patients receive cisplatin IV over 3-6 hours and
pemetrexed disodium IV on day 1. Treatment repeats every 21 days for up to 3 courses in
the absence of disease progression or unacceptable toxicity. Four to six weeks after
completion of chemotherapy, patients undergo surgery.
- Arm II (adjuvant chemotherapy): Patients undergo surgery. Beginning 4-8 weeks after
surgery, patients receive cisplatin and pemetrexed disodium as in arm I.
After completion of study treatment, patients are followed periodically for 5 years and then
annually thereafter.
PROJECTED ACCRUAL: A total of 132 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Successful treatment delivery
Safety Issue:
No
Principal Investigator
Paul Germonpre, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitair Ziekenhuis Antwerpen
Authority:
United States: Federal Government
Study ID:
EORTC-08051
NCT ID:
NCT00389688
Start Date:
August 2006
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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