Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study
1 other identifier
interventional
N/A
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2006
Shorter than P25 for phase_2 breast-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
January 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFebruary 29, 2008
February 1, 2008
January 17, 2006
February 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to treatment failure
TTF rates per arm will be compared at 4 and 6 months
Secondary Outcomes (4)
progression free survival
Patients will be assessed every 2 months during the first 6 months on treatment and every 4 months thereafter until documentation of objective tumor progression or death.
time to progression
Patients will be assessed every 2 months during the first 6 months on treatment and every 4 months thereafter until documentation of objective tumor progression.
toxicity
Acute toxicity will be assessed during the first 8 weeks, sub-acute 8 weeks to 4 months, chronic post 4 months
changes in blood concentrations of angiogenesis-associated surrogate markers and pharmacokinetics
Baseline values will be assessed for predictive potential and assessment on weeks 2,4,8, 12 and thereafter every 2 months they will be analyzed for their capacity to act as surrogate markers of treatment activity
Study Arms (3)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATOR3
ACTIVE COMPARATORInterventions
Patients will take three times a week \[Monday, Wednesday and Friday\] by mouth, a standard dose of soft capsules of vinorelbine given at dose ascribed by randomization procedure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hellenic Cooperative Oncology Grouplead
- University of Ioanninacollaborator
Study Sites (11)
Henry Dunant Hospital
Athens, 11526, Greece
Sotiria Hospital
Athens, 11526, Greece
University Hospital "Attikon"
Athens, 124 62, Greece
Agii Anargiri Cancer Hospital
Athens, 13122, Greece
Hygeia Hospital
Athens, 15123, Greece
Metropolitan Hospital
Athens, 18547, Greece
General Hospital of Chania
Chania, 73300, Greece
University General Hospital of Ioannina, Medical Oncology Dept
Ioannina, 45500, Greece
University Hospital of Patras
Pátrai, 265 00, Greece
"Theagenio" Hospital
Thessaloniki, 54007, Greece
"Papageorgiou" Cancer Hospital
Thessaloniki, 564 03, Greece
Related Publications (1)
Briasoulis 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: 23718900DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evangelos Briasoulis, MD
Assistant Professor of Oncology, Medical School, University of Ioannina
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 17, 2006
First Posted
January 18, 2006
Study Start
January 1, 2006
Study Completion
February 1, 2008
Last Updated
February 29, 2008
Record last verified: 2008-02