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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 August 26, 2014