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
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.
Drug: pemetrexed disodium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Successful treatment delivery [ Designated as safety issue: No ]
- Toxicity (no grade 4) during chemotherapy [ Designated as safety issue: Yes ]
- Overall toxicity (all grades) [ Designated as safety issue: Yes ]
- Progression-free survival and overall survival [ Designated as safety issue: No ]
- Overall clinical response rate (neoadjuvant chemotherapy arm) [ Designated as safety issue: No ]
- Pathologic complete response (neoadjuvant chemotherapy arm) [ Designated as safety issue: No ]
- Resectability rate (neoadjuvant chemotherapy arm) [ Designated as safety issue: No ]
- Surgical morbidity and mortality [ Designated as safety issue: No ]
- Fraction of patients that actually receives chemotherapy (adjuvant chemotherapy arm) [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389688
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Study Chair:||Paul Germonpre, MD||Universitair Ziekenhuis Antwerpen|