Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

February 27, 2008 updated by: Hellenic Cooperative Oncology Group

Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Navelbine
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 Names:
  • 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 Names:
  • Navelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to treatment failure
Time Frame: TTF rates per arm will be compared at 4 and 6 months
TTF rates per arm will be compared at 4 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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
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.
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
Time Frame: Acute toxicity will be assessed during the first 8 weeks, sub-acute 8 weeks to 4 months, chronic post 4 months
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cooperative Oncology Group

Collaborators

University of Ioannina

Investigators

  • Principal Investigator: Evangelos Briasoulis, MD, Assistant Professor of Oncology, Medical School, University of Ioannina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

February 29, 2008

Last Update Submitted That Met QC Criteria

February 27, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE 50/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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