Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

Sponsor

Hellenic Oncology Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00431106

Collaborator

University Hospital of Crete (Other)

144

Enrollment

Locations

Arms

81.1

Duration (Months)

14.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Gemcitabine Drug: Capecitabine Drug: Vinorelbine	Phase 3

Detailed Description

This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Vinorelbine/Gemcitabine (VG)	Drug: Gemcitabine Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles Other Names: Gemzar Drug: Vinorelbine Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles Other Names: Navelbine
Active Comparator: 2 Capecitabine (Cap)	Drug: Capecitabine Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles Other Names: Xeloda

Arm

Intervention/Treatment

Active Comparator: 1

Vinorelbine/Gemcitabine (VG)

Drug: Gemcitabine

Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles

Other Names:

Gemzar

Drug: Vinorelbine

Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles

Other Names:

Navelbine

Active Comparator: 2

Capecitabine (Cap)

Drug: Capecitabine

Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles

Other Names:

Xeloda

Outcome Measures

Primary Outcome Measures

Time to tumor progression between the two treatment arms [1 year]

Secondary Outcome Measures

Overall survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 19-75 years.
Performance status World Health Organization (WHO) 0-2.
Histologically confirmed breast adenocarcinoma.
Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or Taxotere + Farmorubicine).
Measurable disease.
No metastatic central nervous system (CNS) disease.
Less than 25% of myeloproductive bone marrow irradiated.
Adequate bone marrow function (absolute neutrophil count > 1000/mm^{3, platelet count >
100000/mm}3, hemoglobin > 9 gr/mm^3).
Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
Informed consent.

Exclusion Criteria:

Pregnancy or nursing.
Positive pregnancy test.
Psychiatric illness or social situation that would preclude study compliance.
Other concurrent uncontrolled illness.
Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Crete	Heraklion	Crete	Greece	71110
2	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis		Greece
3	"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology	Athens		Greece
4	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine	Athens		Greece
5	"Marika Iliadis" Hospital of Athens, Dept. of Medical Oncology	Athens		Greece
6	401 Military Hospital of Athens	Athens		Greece
7	Air Forces Military Hospital of Athens	Athens		Greece
8	State General Hospital of Larissa, Dept. of Medical Oncology	Larissa		Greece
9	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology	Piraeus		Greece
10	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology	Thessaloniki		Greece