At a glance
ClinicalIndex Comparison Record- ✓Microscopically confirmed non-small cell lung cancer
- ✓NSCLC stages IB, IIA, IIB, or IIIA (including T4 with 2 lesions in one lobe)
- ✓Deemed medically fit for surgical resection by thoracic surgeon
- ✓ECOG performance status 0 or 1
- ✕Metastatic disease (except N1 and ipsilateral/subcarinal N2 nodes)
- ✕N3 lymph nodes or T4 primary tumor with malignant pleural effusion/mediastinal invasion
- ✕Pregnancy
- ✕Other active malignancy within 2 years (except non-melanoma skin cancer and cervical carcinoma in situ)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Neoadjuvant Chemotherapy With Gemcitabine and Pemetrexed in Resectable Non-Small-Cell Lung Cancer (NSCLC) With Pharmacogenomic Correlates.
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, Pemetrexed, and 1 other intervention for Lung Cancer. Completed, enrolled 52 participants across 1 site.
Detailed Summary
This study will evaluate the efficacy and safety of chemotherapy given prior to having lung cancer surgically removed. Patients with resectable non-small cell lung cancer will receive gemcitabine and pemetrexed together for 4 times biweekly. Patients will be seen by a medical oncologist prior to each cycle of chemotherapy given. The medical oncologist will review patient's bloodwork and symptoms prior to approving next cycle of chemotherapy. All patients will then be evaluated with scans to determine response to chemotherapy and to determine if patient is a surgical candidate. These patients will then proceed to surgery to have the lung cancer removed. Follow up visits include bloodwork, scans, and a visit with the medical oncologist every three months for two years, then every six months for three years to monitor for disease recurrence.
Study Details
Timeline
Interventions
Gemcitabine (GemzarR) 1500 mg/m2
Pemetrexed (AlimtaR) 500 mg/m2
When the chemotherapy treatment is completed, the patient's tumor response will be evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). If there is no growth or spread of the cancer on any of these tests, patients will then proceed to have surgery by week 10 to remove the cancer.