Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

• ClinicalTrials.gov Identifier: NCT02450175
• Recruitment Status: Unknown
• First Posted: May 21, 2015
• Last Update Posted: May 21, 2015
• Sponsor: Sinai Hospital of Baltimore
• Information provided by (Responsible Party): Kenneth Miller, M.D., Sinai Hospital of Baltimore

Study Description

Brief Summary:

The purpose of this research study is to understand if platelets in the blood become more active during cancer and specially advanced stages of cancer, in the future the investigators want to see if reducing platelet activity can improve survival in advanced cancer.

Condition or disease	Intervention/treatment	Phase
Neoplasm	Drug: Everolimus; Drug: Letrozole	Not Applicable

Detailed Description:

Hypotheses for proposed study

Platelet reactivity as measured by percentage aggregation in response to agonists such as ADP is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls.

Platelet activation as measured by release of cytokines and vasoactive substances such as VEGF, TGF-beta, and PDGF is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls.

Study Design:

Single center matched case control design; matching variables are age, sex and ethnicity

Inclusion Criteria

Cases:

25 adult patients (>18 years old) with any form of metastatic or advanced stage (TNM stage III or equivalent) solid adenocarcinoma including breast, colon, and lung cancer will be eligible for inclusion in this study with no restrictions related to previous chemotherapy, radiotherapy, biological therapy or surgical management at the time of enrollment or in the past., although we will prefer to recruit them prior to initiating chemotherapy.

Controls:

25 patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic.

Exclusion Criteria:

Thrombocytopenia, defined as a platelet count of <100,000 at the time of recruitment of in the last available laboratory data

History of known bleeding disorder or known platelet dysfunction

Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing

CKD stage IV or greater

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls
• Study Start Date: June 2014
• Estimated Primary Completion Date: June 2016
• Estimated Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Cases; Patients with cancer whose platelets are examined
Placebo Comparator: Control; Patients without cancer whose platelets are examined for comparison	Drug: Everolimus; 10 mg of Everolimus daily (by mouth); Drug: Letrozole; 2.5mg taken daily (by mouth)

Outcome Measures

Primary Outcome Measures :

1. Platelet reactivity [ Time Frame: 1 day ]

Secondary Outcome Measures :

1. Release of vasoactive substances, e.g. TGF Beta, [ Time Frame: 1 day ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Cases:

25 adult patients (>18 years old) with any form of metastatic or advanced stage (TNM stage III or equivalent) solid adenocarcinoma including breast, colon, and lung cancer will be eligible for inclusion in this study with no restrictions related to previous chemotherapy, radiotherapy, biological therapy or surgical management at the time of enrollment or in the past., although we will prefer to recruit them prior to initiating chemotherapy.

Controls:

25 patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic.

Exclusion Criteria:

• Thrombocytopenia, defined as a platelet count of <100,000 at the time of
• recruitment of in the last available laboratory data
• History of known bleeding disorder or known platelet dysfunction
• Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing
• CKD stage IV or greater

Contacts and Locations

Locations

United States, Maryland

SInai Hospital of Baltimore, Inc.; Recruiting

Baltimore, Maryland, United States, 21215

Contact: Judy Bosley, BSN, RN 410-601-6120 jbosley@lifebridgehealth.org

Contact: Paulette Ridgely, RN 410-601-6120 pridgely@lifebridgehealth.org

Principal Investigator: Kenneth Miller, MD

Sponsors and Collaborators

Sinai Hospital of Baltimore

More Information

• Responsible Party: Kenneth Miller, M.D., Medical Oncologist, Sinai Hospital of Baltimore
• ClinicalTrials.gov Identifier: NCT02450175
• Other Study ID Numbers: EOTPCMP
• First Posted: May 21, 2015
• Last Update Posted: May 21, 2015
• Last Verified: May 2015

Keywords provided by Kenneth Miller, M.D., Sinai Hospital of Baltimore:

Platelet Activation; metastasis

Additional relevant MeSH terms:

Everolimus; Letrozole; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists