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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00490373
Collaborator
(none)
52
Enrollment
1
Location
18
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Oct 1, 2003
Actual Study Completion Date :
Apr 1, 2005

Outcome Measures

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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
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

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00490373
Other Study ID Numbers:
  • 8621
  • H3E-SB-S041
First Posted:
Jun 22, 2007
Last Update Posted:
Jun 22, 2007
Last Verified:
Jun 1, 2007
Additional relevant MeSH terms:
Pancreatic Neoplasms
Pemetrexed

Study Results

No Results Posted as of Jun 22, 2007