Metronomic Oral Vinorelbine in Patients With Metastatic Tumors - Full Text View

Sponsors and Collaborators:	Hellenic Cooperative Oncology Group University of Ioannina
Information provided by:	Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00278070

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Non Small Cell Lung Cancer Prostate Cancer	Drug: vinorelbine oral formulation	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lung Cancer Prostate Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study

Further study details as provided by Hellenic Cooperative Oncology Group:

Primary Outcome Measures:

time to treatment failure [ Time Frame: TTF rates per arm will be compared at 4 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

progression free survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
time to progression [ Time Frame: 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. ] [ Designated as safety issue: No ]
toxicity [ Time Frame: Acute toxicity will be assessed during the first 8 weeks, sub-acute 8 weeks to 4 months, chronic post 4 months ] [ Designated as safety issue: Yes ]
changes in blood concentrations of angiogenesis-associated surrogate markers and pharmacokinetics [ Time Frame: 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 ] [ Designated as safety issue: No ]

Study Start Date:	January 2006
Study Completion Date:	February 2008

Arms	Assigned Interventions
1: Active Comparator	Drug: vinorelbine oral formulation 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
2: Active Comparator	Drug: vinorelbine oral formulation 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
3: Active Comparator	Drug: vinorelbine oral formulation 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

Detailed Description:

The purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema. [Metronomic chemotherapy refers to the close, regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no drug-free breaks, over prolonged periods]. Patients with recurrent or metastatic solid tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or 50 mg). Treatment is administered three times a week (Monday, Wednesday and Friday) continuously until disease progression or unacceptable toxicity or to a maximum of 24 months.

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278070

Locations

Greece
University General Hospital of Ioannina, Medical Oncology Dept
Ioannina, Greece, 45500
Hygeia Hospital
Athens, Greece, 15123
Agii Anargiri Cancer Hospital
Athens, Greece, 13122
General Hospital of Chania
Chania, Greece, 73300
University Hospital "Attikon"
Athens, Greece, 124 62
Metropolitan Hospital
Athens, Greece, 18547
"Theagenio" Hospital
Thessaloniki, Greece, 54007
University Hospital of Patras
Patras, Greece, 265 00
Henry Dunant Hospital
Athens, Greece, 11526
Sotiria Hospital
Athens, Greece, 11526
"Papageorgiou" Cancer Hospital
Thessaloniki, Greece, 564 03

Sponsors and Collaborators

Hellenic Cooperative Oncology Group

University of Ioannina

Investigators

Principal Investigator:

Evangelos Briasoulis, MD

Assistant Professor of Oncology, Medical School, University of Ioannina

More Information

Responsible Party:	Hellenic Cooperative Oncology Group ( Evangelos Briasoulis )
Study ID Numbers:	HE 50/05
Study First Received:	January 17, 2006
Last Updated:	February 27, 2008
ClinicalTrials.gov Identifier:	NCT00278070
Health Authority:	Greece: Ministry of Health and Welfare

Keywords provided by Hellenic Cooperative Oncology Group:

Metronomic-therapy
vinorelbine
Recurrent Breast Cancer
Recurrent Non Small Cell Lung Cancer
Metastatic prostate cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Breast Neoplasms
Urogenital Neoplasms
Genital Diseases, Male
Recurrence
Carcinoma

Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type

Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009