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

NCT00490373 | Completed Phase 2

• 2 other identifiers: 8621H3E-SB-S041
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy.

Secondary Outcomes (3)

• To assess tumor response.

• To assess time to event efficacy variables including time to progressive disease and overall survival.

• To characterize the quantitative and qualitative toxicities of pemetrexed in this population of pancreatic cancer patients.

Interventions

pemetrexed DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, Germany

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: October 1, 2003
• Study Completion: April 1, 2005
• Last Updated: June 22, 2007

Record last verified: 2007-06

Locations

DE (1)