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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490373
First received: June 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Pancreatic Cancer
Drug: pemetrexed
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To evaluate the efficacy.

Secondary Outcome Measures:
  • 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.

Enrollment: 52
Study Start Date: October 2003
Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490373

Locations
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, Germany
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00490373     History of Changes
Other Study ID Numbers: 8621, H3E-SB-S041
Study First Received: June 20, 2007
Last Updated: June 20, 2007
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014