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Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

Primary Purpose

Breast Cancer, Non Small Cell Lung Cancer, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
vinorelbine oral formulation
Sponsored by
Hellenic Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Metronomic-therapy, vinorelbine, Recurrent Breast Cancer, Recurrent Non Small Cell Lung Cancer, Metastatic prostate cancer

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henry Dunant Hospital
  • Sotiria Hospital
  • University Hospital "Attikon"
  • Agii Anargiri Cancer Hospital
  • Hygeia Hospital
  • Metropolitan Hospital
  • General Hospital of Chania
  • University General Hospital of Ioannina, Medical Oncology Dept
  • University Hospital of Patras
  • "Theagenio" Hospital
  • "Papageorgiou" Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

time to treatment failure

Secondary Outcome Measures

progression free survival
time to progression
toxicity
changes in blood concentrations of angiogenesis-associated surrogate markers and pharmacokinetics

Full Information

First Posted
January 17, 2006
Last Updated
February 27, 2008
Sponsor
Hellenic Cooperative Oncology Group
Collaborators
University of Ioannina
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1. Study Identification

Unique Protocol Identification Number
NCT00278070
Brief Title
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Official Title
Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Cooperative Oncology Group
Collaborators
University of Ioannina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Non Small Cell Lung Cancer, Prostate Cancer
Keywords
Metronomic-therapy, vinorelbine, Recurrent Breast Cancer, Recurrent Non Small Cell Lung Cancer, Metastatic prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
vinorelbine oral formulation
Other Intervention Name(s)
Navelbine
Intervention Description
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
Primary Outcome Measure Information:
Title
time to treatment failure
Time Frame
TTF rates per arm will be compared at 4 and 6 months
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
toxicity
Time Frame
Acute toxicity will be assessed during the first 8 weeks, sub-acute 8 weeks to 4 months, chronic post 4 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelos Briasoulis, MD
Organizational Affiliation
Assistant Professor of Oncology, Medical School, University of Ioannina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Dunant Hospital
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Sotiria Hospital
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
University Hospital "Attikon"
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Agii Anargiri Cancer Hospital
City
Athens
ZIP/Postal Code
13122
Country
Greece
Facility Name
Hygeia Hospital
City
Athens
ZIP/Postal Code
15123
Country
Greece
Facility Name
Metropolitan Hospital
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
General Hospital of Chania
City
Chania
ZIP/Postal Code
73300
Country
Greece
Facility Name
University General Hospital of Ioannina, Medical Oncology Dept
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
University Hospital of Patras
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
"Theagenio" Hospital
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Facility Name
"Papageorgiou" Cancer Hospital
City
Thessaloniki
ZIP/Postal Code
564 03
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
23718900
Citation
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.
Results Reference
derived

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Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

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