Lung Cancer Clinical Trial
Official title:
Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
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 dividing. Giving more than one drug (combination chemotherapy) before surgery may
make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Giving combination chemotherapy after surgery may kill any tumor cells that remain after
surgery. It is not yet known whether combination chemotherapy is more effective before or
after surgery in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of pemetrexed disodium
and cisplatin and comparing how well they work when given before or after surgery in
treating patients with stage IB or stage II non-small cell lung cancer that can be removed
by surgery.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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