Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments cisplatin, pemetrexed disodium, adjuvant therapy, conventional surgery, neoadjuvant therapy
Phase phase 2
Sponsor Roswell Park Cancer Institute
Start date June 2005
End date April 2012
Trial size 38 participants
Trial identifier NCT00248495, CDR0000441025, RPCI I-31104

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
cisplatin
Given IV
pemetrexed disodium
Given IV
adjuvant therapy
Metastasis prevention/control
conventional surgery
Undergoing tissue removal
neoadjuvant therapy
Tumor Reduction

Primary Outcomes

Measure
Pathologically complete response
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Microscopically confirmed non-small cell lung cancer - Stage IB (T2, N0, M0), IIA (T1, N1, M0), IIB (T2, N1, M0 or T3, N0, M0), or IIIA (T1-3, N1-2, M0) disease - Satellite lesions in one lobe (T4) (stage IIIB) allowed - Meets 1 of the following criteria: - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm in the longest diameter - Evaluable disease, defined as lesions on chest CT scan that are not measurable (e.g., ill-defined masses or mediastinal or hilar adenopathy) - No metastatic disease except peribronchial/hilar lymph nodes (N1) or ipsilateral/subcarinal mediastinal lymph nodes (N2) - No N3 lymph nodes (e.g., contralateral mediastinal/hilar or supraclavicular/scalene) by CT scan or positron emission tomography (PET) scan AND mediastinoscopy - No T4 primary tumor (e.g., mediastinal invasion) - No malignant pleural effusion - Nonmalignant effusions (i.e., negative cytology, non-bloody, and transudate) allowed - Effusions visible only by CT scan and not large enough for safe thoracentesis allowed - No exudative effusion, defined by 1 of the following criteria: - Pleural fluid protein:serum protein ratio > 0.5 - Pleural fluid lactic dehydrogenase (LDH):serum LDH ratio ≥ 0.6 - Pleural fluid LDH > 200 IU/L - No more than 1 area of fludeoxyglucose (FDG) uptake outside the area of the primary lung tumor OR evidence of malignant pleural disease as evidenced by pleural nodules by PET scan - Single areas of FDG uptake will be further evaluated (e.g., by biopsy) for metastatic disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC ≥ 3,000/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL Hepatic - Bilirubin ≤ 1.5 mg/dL - SGOT or SGPT ≤ 1.5 times upper limit of normal Renal - Creatinine clearance ≥ 45 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No psychological, familial, sociological, or geographical situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for lung cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for lung cancer Surgery - No prior surgery for lung cancer - At least 12 weeks since prior major surgery to the chest and abdomen Other - No concurrent aspirin or other nonsteroidal anti-inflammatory drugs for ≥ 2 days before (5 days for drugs with a long half-life [e.g., naproxen, piraoxicam, difunisal, nabumetone, rofecoxib, or celecoxib] or 8 days for long acting agents), during, and for 2 days after completion of each pemetrexed disodium administration - No concurrent participation in another study involving chemotherapy or radiotherapy

Additional Information

Official title Molecular and Genetic Changes in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Cisplatin and Alimta - Phase II Study
Principal investigator Grace K. Dy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Roswell Park Cancer Institute.