Trial of Pemetrexed for Patients With Pancreatic Cancer Which Cannot be Treated With Surgery or is Metastatic

A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas

This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine.

Inclusion Criteria:

• Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997), and not amenable to resection with curative intent.
• Prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed).
• Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et al. 2000), defined as: At least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral CT scans. Ultrasound and X-ray are NOT allowed to measure or follow lesions.

Exclusion Criteria:

• Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and Eckerman 1987)
• Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer.
• Prior systemic chemotherapy with 5-FU.
• Patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment.
• Radiotherapy within the last 4 weeks before study entry