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Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

This study has been completed.
Sponsor:
Collaborator:
University of Ioannina
Information provided by:
Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00278070
First received: January 17, 2006
Last updated: February 27, 2008
Last verified: February 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study

Resource links provided by NLM:

U.S. FDA Resources

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
Active Comparator: 1 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
Other Name: Navelbine
Active Comparator: 2 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
Other Name: Navelbine
Active Comparator: 3 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
Other Name: Navelbine

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

No publications provided

Responsible Party: Evangelos Briasoulis, Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00278070     History of Changes
Other Study ID Numbers: HE 50/05
Study First Received: January 17, 2006
Last Updated: February 27, 2008
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vinorelbine
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 21, 2013