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Non-Small Cell Lung CancerPhase 1NCT00476216

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

A Phase 1 study testing Combination of Arixtra with chemotherapy in people with Non-Small Cell Lung Cancer and Venous Thromboembolism, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Combination of Arixtra with chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Sep 2007to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Combination of Arixtra with chemotherapy
Keywords
Non-Small Cell Lung Cancer, Venous Thromboembolism, VTE, Arixtra
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination of Arixtra with chemotherapyDrug

    Also called Fondaparinux

    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.

Study groups in NCT00476216
Study groupRoleWhat they receive
Combination of Arixtra with chemotherapyExperimentalCarboplatin 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)
Receives: Drug: Combination of Arixtra with chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Every 3 weeks prior to each cycle of therapy.

Secondary outcomes (1)

  1. Clinically evident Venous Thromboembolism (VTE)

    Measured: Every 3 weeks prior to each cyle of therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00476216
Sponsor's protocol ID
F070309006
Other IDs
UAB 0649
Status last verified
Mar 2014
First submitted
16 May 2007
Last updated
5 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Combination of Arixtra with chemotherapy in people with Non-Small Cell Lung Cancer and Venous Thromboembolism, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00476216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.

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