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Carboplatin 6 AUC q 21 days; Paclitaxel 200 mg/m2 q 21 days. Cohort I: Arixtra 2.5 mg SQ qd x 21 days; Cohort II: Arixtra weight-based dose (D1-2)followed by Arixtra 2.5 SQ q day (D3-21)

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.

Combination of Arixtra with chemotherapy

Francisco Robert, M.D.

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.

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.

Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer

Phase I Feasibility Study of the Combination of Fondaparinux (Arixtra) With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

University of Alabama at Birmingham

Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer	NCT00476216	Non-Small Cell ... Venous Thromboe...	Combination of ...	18 Years - 79 Years	University of Alabama at Birmingham
Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer	NCT00476216	Non-Small Cell ... Venous Thromboe...	Combination of ...	18 Years - 79 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for combination of arixtra with chemotherapy