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

Lilly

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00490373

H3E-SB-S041

8621

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)