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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Pancreatic Cancer, Nonresectable Pancreatic Cancer

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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 MedicineBaltimore, Maryland  21205
US OncologyHouston, Texas  77060