Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer; Venous Thromboembolism
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 1

Summary: 
      There is a direct association between cancer and thrombosis (blood clots). The purpose of
      this study is to determine the best dose of an antithrombotic (prevents blood clots) agent
      called fondaparinux in non-small cell lung cancer(NSCLC). Patients will also receive
      chemotherapy.
    

Detailed description: 
      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:

      Cohort 1:

      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
      chemotherapy.

      Cohort 2:

      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.
    

Intervention name(s): Combination of Arixtra with chemotherapy
Intervention type(s): Drug
Intervention description(s): Single arm, 2 cohort feasibility study:
Carboplatin will be administered intravenously over approximately 30 minutes after paclitaxel infusion is completed and the dose will be calculated on basis of an area under the curve (AUC) of 6, according to the formula administered every 21 days. Paclitaxel will be administered 200 mg/m2 over 3 hours every 21 days.
Patients in both cohorts 1 & 2 will receive standard chemotherapy alone during cycle 1.
Cohort 1:During subsequent cycles (2-4) patients will receive a daily prophylactic dose (day 1 through 21) of Arixtra and continue 21 days after the last course of chemotherapy.
Cohort 2: 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 Arixtra for the first 2 days of each chemotherapy cycle followed by a daily prophylactic dose of Arixtra (day 3 through 21) until the next course of chemotherapy.
Other intervention name(s): Fondaparinux
Intervention MeSH terms: Fondaparinux
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Small Cell Lung Cancer; Venous Thromboembolism; VTE; Arixtra