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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 February 2013
• Main ID: NCT00476216
• Date of registration: 16/05/2007
• Primary sponsor: University of Alabama at Birmingham
• Public title: Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer
• Scientific title: Phase I Feasibility Study of the Combination of Fondaparinux (Arixtra) With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
• Date of first enrolment: September 2007
• Target sample size: 27
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00476216
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Francisco Robert, M.D.
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Venous Thromboembolism

Intervention(s)

Drug: Combination of Arixtra with chemotherapy

Primary Outcome(s)

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.]

Secondary Outcome(s)

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

Secondary ID(s)

F070309006

UAB 0649

Source(s) of Monetary Support

Please refer to primary and secondary sponsors