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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490373
• Other study ID #: 8621
• Secondary ID: H3E-SB-S041
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: October 2003
• Est. completion date: April 2005

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• pemetrexed

Locations

Country	Name	City	State
Germany	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy.
Secondary	To assess tumor response.
Secondary	To assess time to event efficacy variables including time to progressive disease and overall survival.
Secondary	To characterize the quantitative and qualitative toxicities of pemetrexed in this population of pancreatic cancer patients.

External Links

•   Lilly Clinical Trial Registry