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

NCT00476216 | Completed Phase 1 DMC

• 2 other identifiers: F070309006UAB 0649
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer; Venous Thromboembolism

Keywords

Non-Small Cell Lung Cancer; Venous Thromboembolism; VTE; Arixtra

Outcome Measures

Primary Outcomes (1)

• The tolerability and safety of the combination of fondaparinux with standard chemotherapy (carboplatin/paclitaxel).

  Every 3 weeks prior to each cycle of therapy.

Secondary Outcomes (1)

• Clinically evident Venous Thromboembolism (VTE)

  Every 3 weeks prior to each cyle of therapy.

Study Arms (1)

Combination of Arixtra with chemotherapy

EXPERIMENTAL

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)

Drug: Combination of Arixtra with chemotherapy

Interventions

Combination of Arixtra with chemotherapy DRUG

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.

Also known as: Fondaparinux

Combination of Arixtra with chemotherapy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Venous Thromboembolism

Interventions

Drug Therapy; Fondaparinux

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Francisco Robert, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)