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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00706069
Other study ID # CT/07.06
Secondary ID
Status Completed
Phase Phase 1
First received June 25, 2008
Last updated December 14, 2009
Start date June 2008
Est. completion date July 2009

Study information

Verified date December 2009
Source Hellenic Oncology Research Group
Contact n/a
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Interventional

Clinical Trial Summary

This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients


Description:

The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been studied in a phase [I]/[II], with favourable profile of toxicity in pretreated patients with anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003).

In a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR) in 21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin Oncol 19: Abstract 420, 2000)


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Histologically confirmed metastatic breast cancer

- Age 18-75 years

- Bidimensionally measurable or evaluable disease

- Performance status (PS) 0-2 (ECOG)

- Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment

- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and adequate bone marrow function(neutrophils = 1.5x 109 /L, and platelets = 100x 109 /L)

- At least three weeks from completion of irradiation

- Life expectancy = 12 weeks

- Patients able to take oral medication

- written informed consent

Exclusion Criteria:

- Active infection

- Brain metastases

- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

- Malnutrition (loss of = 20% of the original body weight)

- Psychiatric illness or social situation that would preclude study compliance

- Pregnant or lactating women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Vinorelbine oral
Vinorelbine at dose levels of 30mg, 40mg, 50mg, 60mg oral every Monday, Wednesday and Friday
Capecitabine
Capecitabine at dose levels of 800 mg/m2, 950mg/m2, 1100mg/m2, 1250mg/m2 per os from day 1 to day 14 every 21 days

Locations

Country Name City State
Greece University General Hospital of Alexandroupolis, Dept. of Medical Oncology Alexandroupolis
Greece "IASO" General Hospital of Athens, 1st Dep of Medical Oncology Athens
Greece "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology Athens
Greece University Hospital of Crete, Dep of Medical Oncology Heraklion

Sponsors (2)

Lead Sponsor Collaborator
Hellenic Oncology Research Group University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination Toxicity assessment at 1st cycle Yes
Primary Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination. Toxicity assessment at 1st cycle Yes
Secondary Response Rate Response evaluation at 3rd and 6th cycle by CT's or MRI No
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