Phase II Trial of Pemetrexed in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Biopsy proven, incompletely resected or unresectable BAC. Selected Stage IIIB cytology-confirmed malignant pleural effusion or Stage IV as outlined in Section 4.0. Pts must have measurable OR non-measurable disease documented by CT. Measurable disease assessed within 28 days prior and non-measurable within 42 days prior. Pleural effusions, ascites, and lab parameters are not acceptable as only evidence of disease. Pts may have had up to two prior therapies (including EGFR inhibitor) prior to 28 days (or 14 days for EGFR TKI inhibitor)since the last treatment before registration. Pts treated with ZD1839 (gefitinib) or OSI-774 (erlotinib) must have progressed after treatment. No prior treatment with pemetrexed. No brain mets. Pts may have had and recovered from radiation therapy prior to 28 days before registration. Measurable or non-measurable disease must be present outside previous radiation field or new lesion inside the port must be present. If palliative radiation, pts must have completed 14 days prior and recovered at registration. Sx (thoracic or other major sx) allowed at least 28 days prior with pts recovered from all toxicities. Adequate hepatic function: serum bilirubin</=1.5 x IULN. If there are liver mets, SGOT/SGPT </= 5 x IULN. If there are bone mets, Alk. Phos. </= 5 x IULN. Adequate renal function tested 28 days prior: serum creat. </= 1.5 IULN OR calculated or measured creat. clearance >/= 45ml/min using formula outlined in Section 5.8. Pts must have ANC >/= 1,500/mcl and plt. count >/=75,000/mcl obtained 28 days prior. Zubrod 0-2. Must be willing to provide smoking history. Must have IRB approval of S9925 and patients must be offered participation in S9925. Must not be receiving or planning to receive sx or any other therapy directed at BAC. Must not be receiving HAART. Pts must not have history of allergic rxns to compounds similar to pemetrexed. Must be able to swallow pills. No other prior malignancy except for those outlined in Section 5.19. No pregnant or nursing women.