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

March 3, 2014 updated by: Francisco Robert,MD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama At Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination of Arixtra with chemotherapy
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

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 Names:
  • Fondaparinux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The tolerability and safety of the combination of fondaparinux with standard chemotherapy (carboplatin/paclitaxel).
Time Frame: Every 3 weeks prior to each cycle of therapy.
Every 3 weeks prior to each cycle of therapy.

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinically evident Venous Thromboembolism (VTE)
Time Frame: Every 3 weeks prior to each cyle of therapy.
Every 3 weeks prior to each cyle of therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Francisco Robert, M.D., University of Alabama At Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F070309006
  • UAB 0649 (Other Identifier: Institutional study protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on Combination of Arixtra with chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe