Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

NCT ID: NCT00278070

Last Updated: 2008-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-02-29

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

vinorelbine oral formulation

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

vinorelbine oral formulation

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

vinorelbine oral formulation

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Navelbine

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ioannina

OTHER

Sponsor Role: collaborator

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Hellenic Cooperative Oncology Group

Principal Investigators

Evangelos Briasoulis, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Oncology, Medical School, University of Ioannina

Locations

Henry Dunant Hospital

Athens, , Greece

Sotiria Hospital

Athens, , Greece

University Hospital "Attikon"

Athens, , Greece

Agii Anargiri Cancer Hospital

Athens, , Greece

Hygeia Hospital

Athens, , Greece

Metropolitan Hospital

Athens, , Greece

General Hospital of Chania

Chania, , Greece

University General Hospital of Ioannina, Medical Oncology Dept

Ioannina, , Greece

University Hospital of Patras

Pátrai, , Greece

"Theagenio" Hospital

Thessaloniki, , Greece

"Papageorgiou" Cancer Hospital

Thessaloniki, , Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 23718900 (View on PubMed)

Other Identifiers

HE 50/05

Identifier Type: -

Identifier Source: org_study_id