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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Fondaparinux; PENTA

Criteria

Inclusion Criteria:

• Histologic or cytologic diagnosis of Non-Small Cell Lung Cancer.

• Stage IV Non-Small Cell Lung Cancer.

• Measurable or assessable tumor parameters according to RECIST criteria.

• ECOG Performance Status 0-2.

• Age between 18 and 79 years (in the State of Alabama > 18).

• Adequate hematologic, coagulation, liver and renal function, defined as:

• Absolute neutrophil count (ANC) ≥ 1500/µL

• Platelet count ≥ 100,000/µL

• Serum Glutamic Oxaloacetic Transaminase(SGOT)/Serum Glutamic Pyruvic Transaminase(SGPT) ≤ 2.5 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present

• Total bilirubin value ≤ 1.5 x upper limit of normal

• Serum creatinine value ≤ 1.5 x upper limit of normal

• Normal prothrombin time and partial thromboplastin time

• Fully recovered from any previous surgery (at least 4 weeks since major surgery).

• Must have recovered from prior radiation therapy (at least 3 weeks).

• All participants must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.

• Must provide written informed consent and authorization to use and disclose health information.

• No prior chemotherapy.

Exclusion Criteria:

• Active bleeding disorder.

• Evidence of hemoptysis. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator.

• Previous history of Venous Thromboembolism (VTE) within 12 months and requiring active anticoagulation therapy.

• Concurrent cancer chemotherapy, biologic therapy or radiotherapy.

• Administration of any investigational drug within 28 days prior to administration of the current therapy.

• Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery and have stable disease.

• Concurrent serious infection.

• Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study.

• History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years.

• Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial.

• Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions.

• Pregnant or lactating women.

• Creatinine clearance < 30 mL/min.

• Patient body weight < 50 kg.