A Phase I Trial of Preoperative Carboplatin or Cisplatin and Pemetrexed With Thoracic Radiation Therapy Followed by Lobectomy in Resectable Stage III Patients With Non-Squamous Non Small Cell Lung Cancer (NSCLC)
- Histologically and cytologically confirmed non-squamous NSCLC.
- Resectable T3, and or N2 disease (T3N1, and resectable T1-3N2 multi-station non-bulky
with no nodal station being more than 2 cm on preoperative workup, T4N0-1
- Resectable T3 includes patients with a satellite lesion in the same lobe as the
- Male or Female, aged > or = 18 years and be able to give informed consent.
- Tumor should be technically operable with a lobectomy, bilobectomy or a sleeve
- Patient should be medically operable
- ECOG Performance Status 0 or 1.
- Adequate bone marrow, hepatic and renal function assessed within 28 days
- Signed informed consent.
- Women of childbearing potential should have negative pregnancy test prior to
enrollment to study.
- Men with partners in the childbearing age group and women of childbearing potential
must use effective contraception while on treatment and for 6 months thereafter.
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the
day of, and 2 days following administration of Pemetrexed.
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- Patients must have a negative MRI or CT Scan of the brain.
- Patients who have had chemotherapy or radiation therapy within 4 weeks prior to
entering the study or those who have not recovered from adverse events due to agents
administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds or other agents used in study.
- Pregnant or lactating women.
- Male patients with female sexual partners in the reproductive age group who refuse to
use effective methods of contraception will be excluded from the trial.
- Patients with concurrent serious infections.
- Patients with an unstable or serious concurrent medical condition are excluded.
- Presence of third space fluid which cannot be controlled by drainage.
- Weight loss > 10 percent from baseline weight.
- HIV-positive patients on combination antiretroviral therapy are ineligible
- Patients with hypercalcemia will be excluded.
- Patients who require a pneumonectomy will be excluded.