A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas
- 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
- 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.
- Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and
- 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
- Radiotherapy within the last 4 weeks before study entry