Clinical trial · Interventional
Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer
Phase I Feasibility Study of the Combination of Fondaparinux (Arixtra) With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
NCT00476216CI-TRIAL-00013940completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of Arixtra with chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination of Arixtra with chemotherapy
- description
- 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)
- interventionNames
- Drug: Combination of Arixtra with chemotherapy
Primary outcomes (1)
- measure
- The tolerability and safety of the combination of fondaparinux with standard chemotherapy (carboplatin/paclitaxel).
- timeFrame
- Every 3 weeks prior to each cycle of therapy.
Secondary outcomes (1)
- measure
- Clinically evident Venous Thromboembolism (VTE)
- timeFrame
- Every 3 weeks prior to each cyle of therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.