This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal cancer.
* This research study is a Phase II/III clinical trial. --The goal of this trial is to evaluate if isoquercetin can prevent blood clots in patients with pancreas, non small cell lung cancer or colorectal cancer. In the Phase II part of this study, the investigators are looking for the dose of isoquercetin to reduce D-dimer and demonstrate safety. * Phase III Endpoint and Treatment Plan * Primary Endpoint for Phase III portion of protocol: Cumulative incidence of VTE. * Following the completion of the phase II portion, enrolled patients will be randomized 1:1 to Arm C (isoquercetin) or Arm D (placebo). The dose for Arm C will be determined after evaluation of the Phase II portion of the trial. The protocol will be amended when the decision is made whether to proceed to Phase III and what dose to use for Arm C. The study will be double-blinded to treatment arm. Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days. * At BIDMC, optional blood draw will be performed at time 0 and 4 hours following the first dose of study drug.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
VA Northern California Health Care System
Sacramento, California, United States
VA Connecticut Healthcare System
West Haven, Connecticut, United States
Percent Change in D-dimer Value
D-dimer concentrations will be compared for each patient at day 0 and day 56 by a paired-t test analysis. Analysis will be performed on an intention to treat basis for patients who undergo randomization and completed the baseline and day 56 D-dimer assessments.
Time frame: Baseline, 56 Day
Number of Participants With Hemorrhage
Investigating the safety of isoquercetin in cancer patients
Time frame: study visits until day 56
Cumulative Incidence of VTE at 56 Days
To investigate the cumulative incidence of VTE according to tissue factor bearing microparticle status (and isoquercetin randomization).
Time frame: 56 days
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...and 1 more locations