Breast CancerPhase 2NCT00278070
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
A Phase 2 study testing vinorelbine oral formulation in people with Breast Cancer and Non Small Cell Lung Cancer, run by Hellenic Cooperative Oncology Group at 11 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Breast Cancer, Non Small Cell Lung Cancer, Prostate Cancer
- What is being tested?
- vinorelbine oral formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 11 sitesGreece
- Study dates
- Jan 2006to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Greece11 sites
Henry Dunant Hospital
Athens, 11526
Sotiria Hospital
Athens, 11526
University Hospital "Attikon"
Athens, 124 62
Agii Anargiri Cancer Hospital
Athens, 13122
Hygeia Hospital
Athens, 15123
Metropolitan Hospital
Athens, 18547
General Hospital of Chania
Chania, 73300
University General Hospital of Ioannina, Medical Oncology Dept
Ioannina, 45500
University Hospital of Patras
Pátrai, 265 00
"Theagenio" Hospital
Thessaloniki, 54007
"Papageorgiou" Cancer Hospital
Thessaloniki, 564 03
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Non Small Cell Lung Cancer, Prostate Cancer
- Being tested
- vinorelbine oral formulation
- Keywords
- Metronomic-therapy, vinorelbine, Recurrent Breast Cancer, Recurrent Non Small Cell Lung Cancer, Metastatic prostate cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinorelbine oral formulationDrug
Also called Navelbine
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: vinorelbine oral formulation |
| 2 | Active comparator | Not described Receives: Drug: vinorelbine oral formulation |
| 3 | Active comparator | Not described Receives: Drug: vinorelbine oral formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to treatment failure
Measured: TTF rates per arm will be compared at 4 and 6 months
Secondary outcomes (4)
progression free survival
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJan 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ioannina
- Investigators
- Evangelos Briasoulis, MD, Principal investigator, Assistant Professor of Oncology, Medical School, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278070
- Sponsor's protocol ID
- HE 50/05
- Status last verified
- Feb 2008
- First submitted
- 17 Jan 2006
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23718900
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study
- ClinicalTrials.gov ID
- NCT00278070
- Acronym / sponsor ID
- HE 50/05
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- University of Ioannina
- Study start
- Jan 2006
- Study completion
- Feb 2008 (actual)
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: vinorelbine oral formulation |
| 2 | Active comparator | Drug: vinorelbine oral formulation |
| 3 | Active comparator | Drug: vinorelbine oral formulation |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (15 listed)
- 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:
- Hypertension that cannot be controlled with medications (> 150/100 mmHg despite optimal medical therapy)
- Ongoing anti-coagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vinorelbine oral formulationAlso: NavelbinePatients 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 | Drug | 1, 2, 3 |
Primary outcome
time to treatment failure
Time frame: TTF rates per arm will be compared at 4 and 6 months
4 secondary outcomes
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.
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.
toxicity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2008.
- Derived from this study: PubMed 23718900Briasoulis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelos Briasoulis, MD principal investigator
Assistant Professor of Oncology, Medical School, University of Ioannina
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vinorelbine oral formulation in people with Breast Cancer and Non Small Cell Lung Cancer, run by Hellenic Cooperative Oncology Group at 11 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to treatment failure (time frame: TTF rates per arm will be compared at 4 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00278070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2008.