Metronomic Oral Vinorelbine in Patients With Metastatic Tumors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278070
• Other study ID #: HE 50/05
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2006
• Last updated: February 27, 2008
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Hellenic Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis
• Non Small Cell Lung Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Greece	Agii Anargiri Cancer Hospital	Athens
Greece	Henry Dunant Hospital	Athens
Greece	Hygeia Hospital	Athens
Greece	Metropolitan Hospital	Athens
Greece	Sotiria Hospital	Athens
Greece	University Hospital "Attikon"	Athens
Greece	General Hospital of Chania	Chania
Greece	University General Hospital of Ioannina, Medical Oncology Dept	Ioannina
Greece	University Hospital of Patras	Patras
Greece	"Papageorgiou" Cancer Hospital	Thessaloniki
Greece	"Theagenio" Hospital	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group	University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to treatment failure		TTF rates per arm will be compared at 4 and 6 months	Yes
Secondary	progression free survival		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.	No
Secondary	time to 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.	No
Secondary	toxicity		Acute toxicity will be assessed during the first 8 weeks, sub-acute 8 weeks to 4 months, chronic post 4 months	Yes
Secondary	changes in blood concentrations of angiogenesis-associated surrogate markers and pharmacokinetics		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	No