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

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ClinicalTrials.gov Identifier: NCT00490373
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : June 22, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas
Study Start Date : October 2003
Actual Study Completion Date : April 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the efficacy.

Secondary Outcome Measures :
  1. To assess tumor response.
  2. To assess time to event efficacy variables including time to progressive disease and overall survival.
  3. To characterize the quantitative and qualitative toxicities of pemetrexed in this population of pancreatic cancer patients.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490373


Locations
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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
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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
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00490373    
Other Study ID Numbers: 8621
H3E-SB-S041
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: June 22, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors