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A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

This study has been completed.
Information provided by:
Cell Genesys Identifier:
First received: October 27, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
To evaluate the safety and effectiveness of CG8020 and CG2505.

Condition Intervention Phase
Metastatic Pancreatic Cancer
Nonresectable Pancreatic Cancer
Biological: CG 8020 and CG 2505
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

Resource links provided by NLM:

Further study details as provided by Cell Genesys:

Primary Outcome Measures:
  • Safety
  • Efficacy measured by clinical benefit response
  • Progression-free survivial
  • Overall survival

Estimated Enrollment: 50
Study Start Date: June 2002
Estimated Study Completion Date: June 2004
Detailed Description:
To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
  • Chemotherapy naïve or chemotherapy experienced pancreatic cancer

Exclusion Criteria:

  • Prior cancer vaccines or gene therapy
  • History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
  • History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor
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Please refer to this study by its identifier: NCT00245362

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
United States, Texas
US Oncology
Dallas, Texas, United States
Sponsors and Collaborators
Cell Genesys
  More Information Identifier: NCT00245362     History of Changes
Other Study ID Numbers: P-0011
Study First Received: October 27, 2005
Last Updated: October 27, 2005

Keywords provided by Cell Genesys:
cancer vaccine
pancreatic cancer
metastatic pancreatic cancer
unresectable pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases processed this record on April 26, 2017