Clinical trial NCT00248495
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage II non-small cell lung cancer stage I non-small cell lung cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2005-06-08; Completion date: 2017-04-05
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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 dividing. Giving more than one drug (combination chemotherapy) and giving them before and after surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin before and after surgery works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the pathologic complete response in patients with stage IB-IIIB non-small cell lung cancer treated with neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by surgery and adjuvant pemetrexed disodium and cisplatin.

Secondary

* Determine the adverse events of this regimen in these patients.
* Determine the overall and disease-free survival of patients treated with this regimen.
* Correlate response with the presence or absence of ERCC1 and DHFR, thymidylate synthase, DPD, and GARFT in patients treated with this regimen.
* Correlate the fragile site on chromosome 12 within the SMRT gene with metastasis after definitive treatment with this regimen in these patients.

OUTLINE:

* Neoadjuvant chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses. Patients are then evaluated for disease resectability. Patients with no evidence of disease progression proceed to thoracotomy within the next 28-48 days.
* Thoracotomy: Patients found to have unresectable disease during thoracotomy receive further treatment off study. Patients with resectable disease undergo complete surgical resection of the tumor. Forty to eighty days later, patients proceed to adjuvant chemotherapy.
* Adjuvant chemotherapy: Patients receive pemetrexed disodium and cisplatin as before for 2 courses.

Patients with progressive disease after completion of neoadjuvant chemotherapy are followed every 6 months. All other patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study over 6.5 years.

Arms: arm 1: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses
Interventions: intervention 1: cisplatin intervention 2: pemetrexed disodium intervention 3: adjuvant therapy intervention 4: conventional surgery intervention 5: neoadjuvant therapy
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Metastasis prevention/control intervention 4: Undergoing tissue removal intervention 5: Tumor Reduction

Protocol documents: