Clinical trial · Interventional
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study
NCT00278070CI-TRIAL-00001170completedPhase 2ClinicalTrials.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)
Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic schedule three times a week: on Monday, Wednesday and Friday.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vinorelbine oral formulation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: vinorelbine oral formulation
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: vinorelbine oral formulation
- type
- ACTIVE_COMPARATOR
- label
- 3
- interventionNames
- Drug: vinorelbine oral formulation
Primary outcomes (1)
- measure
- time to treatment failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Ages 16 - 75 years * Genders: both * Performance status 0-2 according to the World Health Organization (WHO) scale * Life expectancy of at least 16 weeks * Adequate bone marrow, hepatic and renal functions * Absence of brain metastasis * Metastatic/locally advanced refractory prostate, breast or non-small cell lung cancer previously treated with no more than two chemotherapeutic regimens * White blood cells \>= 3500/mm\^3 * Absolute neutrophil count \>= 1500/mm\^3 * Platelets \>= 100,000/mm\^3 * Total serum bilirubin less than 1.5 mg/dl * Serum transaminases less than 2.0 x upper normal limit (UNL) unless attributed to liver metastases * Serum creatinine within normal range Exclusion Criteria: * Major active infection * More than two prior chemotherapy regimens for metastatic disease * Any of the following within the 12 months prior to starting the study treatment: * myocardial infarction, * severe/unstable angina, * coronary/peripheral artery bypass graft, * congestive heart failure, * cerebrovascular accident or transient ischemic attack, or pulmonary embolism, * cardiac dysrhythmias of grade \>/= 2, * atrial fibrillation of any grade, or * heart rate corrected interval (QTc) \> 450 msec for males or \> 470 msec for females. * Hypertension that cannot be controlled with medications (\> 150/100 mmHg despite optimal medical therapy) * Ongoing anti-coagulation therapy * Pregnancy or breastfeeding * Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration; or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
References
Publications (1)
- DERIVEDBriasoulis E, Aravantinos G, Kouvatseas G, Pappas P, Biziota E, Sainis I, Makatsoris T, Varthalitis I, Xanthakis I, Vassias A, Klouvas G, Boukovinas I, Fountzilas G, Syrigos KN, Kalofonos H, Samantas E. Dose selection trial of metronomic oral vinorelbine monotherapy in patients with metastatic cancer: a hellenic cooperative oncology group clinical translational study. BMC Cancer. 2013 May 29;13:263. doi: 10.1186/1471-2407-13-263. PMID 23718900