Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT01664169
First received: August 10, 2012
Last updated: June 17, 2013
Last verified: August 2012
  Purpose

RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic cancer treated on study CALGB-80303.


Condition Intervention
Pancreatic Cancer
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Validation of Circulating Biomarkers Using the Immunological Multiparameter Chip Technology (IMPACT) on Plasma Specimens Collected on CALGB 80303

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Median OS/PFS (95% CI) estimated from Kaplan-Meier curves for patients with low and patients with high biomarker levels [ Designated as safety issue: No ]
  • Stratified OS/PFS hazard ratio (HR) (95% CI) from the Cox model for patients with low and patients with high biomarker levels [ Designated as safety issue: No ]
  • Stratified OS/PFS HR (95% CI) from Cox model by quartile of VEGF-A levels [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of responders and the stratified objective response (OR) from logistic regression for patients with high and low concentration of biomarker [ Designated as safety issue: No ]

Enrollment: 0
Detailed Description:

OBJECTIVES:

  • To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for overall survival (OS) in study BO17706 can be replicated in study CALGB-80303 using the same Immunological Multiparameter Chip Technology (IMPACT) assay.
  • To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for progression-free survival (PFS), and other circulating biomarkers in study BO17706, can be replicated in study CALGB-80303 using the same IMPACT assay.
  • To explore the relationship between efficacy and other biomarkers measured in the plasma samples.

OUTLINE: The samples required for this study are stored in the CALGB Pathology Coordinating Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No additional samples are required from patients.

The following markers are analyzed in EDTA plasma samples using the Immunological MultiParameter Chip Technology (IMPACT) a Roche proprietary multiplex enzyme-linked immunosorbent assay (ELISA) platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Patients must have been registered to CALGB-80303

    • Histologically or cytologically confirmed adenocarcinoma of the pancreas
    • Locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664169

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Herbert Pang, PhD CALGB Statistical Office at Duke University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier: NCT01664169     History of Changes
Other Study ID Numbers: A151201, CDR0000738204, NCI-2012-01994
Study First Received: August 10, 2012
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
stage IIB pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014