Phase I Feasibility Study of the Combination of Fondaparinux (Arixtra) With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
This is a single center, open-labeled, single arm phase 1 feasibility study in patients with
newly diagnosed stage IV NSCLC. To evaluate the change in the biologic parameters measured,
two cohorts of patients will receive altered dosing regimens of fondaparinux starting with
the second cycle of chemotherapy. The biologic parameters measured during the first cycle
of chemotherapy will serve as a control for each patient. Chemotherapy consists of 3-week
cycles of carboplatin and paclitaxel. The absolute maximum length of therapy with
fondaparinux will be 3 months, regardless of which cohort the patient is assigned.
This study consists of 2 cohorts:
Patients in cohort 1 will receive standard chemotherapy alone during cycle 1. During
subsequent cycles (2-4) patients will receive a daily prophylactic dose (day 1 through 21)
of fondaparinux. The anticoagulation will continue 21 days after the last course of
Patients in cohort 2 will receive standard chemotherapy alone during cycle 1. During
subsequent cycles, the patient will receive a therapeutic weight based dose of fondaparinux
for the first 2 days of each chemotherapy cycle followed by a daily prophylactic dose of
fondaparinux (day 3 through 21) until the next course of chemotherapy.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The tolerability and safety of the combination of fondaparinux with standard chemotherapy (carboplatin/paclitaxel).
Every 3 weeks prior to each cycle of therapy.
Francisco Robert, M.D.
University of Alabama at Birmingham
United States: Institutional Review Board
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|