Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer - Full Text View

Sponsored by:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00480597

Purpose

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.

For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks

Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks

Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: gemcitabine Drug: cisplatin Drug: vinorelbine Drug: capecitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cisplatin Vinorelbine Gemcitabine Gemcitabine hydrochloride Vinorelbine tartrate Capecitabine

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

Response rate [ Time Frame: one year after last patient in ]

Secondary Outcome Measures:

Time to progression [ Time Frame: one year after last patient in ]
Overall Survival [ Time Frame: one year after last patient in ]
Toxicity

Enrollment:	141
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed metastatic breast cancer
All patients were required to give written informed consent
Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy.
Antracycline-pretreatment during aduvant or palliative first line therapy
Bidimensionally measurable lesion outside a previous radiation field.
Age >= 18 years
Karnofsky Performance status >= 70%
Adequate heamatological, renal, cardiac and hepatic function
No radiation of the measurable lesion during the study was allowed.

Exclusion Criteria:

Only bone metastases
Active infection
Previous treatment with one of the study drugs
Application of other cytotoxic chemotherapy
Insufficent renal function (creatinine clearance < 60ml/min)
Known DPD deficiency
clinically unstable brain metastasis
pregancy or lactation
other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480597

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators

Principal Investigator:

Volker Heinemann, PhD, MD

University of Munich - Klinikum Grosshadern

More Information

No publications provided

Study ID Numbers:	Gemcitabin 02 MC
Study First Received:	May 30, 2007
Last Updated:	May 30, 2007
ClinicalTrials.gov Identifier:	NCT00480597 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:

gemcitabine
vinorelbine
cisplatin
capecitabine
pretreated metastatic breast cancer

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Capecitabine
Skin Diseases
Immunologic Factors
Breast Neoplasms
Antiviral Agents

Immunosuppressive Agents
Vinorelbine
Cisplatin
Radiation-Sensitizing Agents
Gemcitabine
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Capecitabine
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vinorelbine
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009