Trial Information
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Authority:
United States: Food and Drug Administration
Study ID:
P-0011
NCT ID:
NCT00245362
Start Date:
June 2002
Completion Date:
June 2004
Related Keywords:
- Metastatic Pancreatic Cancer
- Nonresectable Pancreatic Cancer
- cancer vaccine
- pancreatic cancer
- metastatic pancreatic cancer
- unresectable pancreatic cancer
- immunotherapy
- Pancreatic Neoplasms
Name | Location |
|---|
| Johns Hopkins University School of Medicine |
Baltimore, Maryland 21205 |
| US Oncology |
Houston, Texas 77060 |
