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Sponsors and Collaborators: |
Ludwig-Maximilians - University of Munich Eli Lilly and Company |
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Information provided by: | Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT00450762 |
The rational for this trial is given by the knowledge that gemcitabine acts as a potent inhibitor of DNA repair and therefore may prevent adequate repair of platin-induced DNA damage. Gemcitabine is an excellent choice for combination therapy by its unique mechanism of action and favourable toxicity profile. The combination of gemcitabine and cisplatin was shown to be effective in several trials, producing response rates of 30-52 % in patients with pretreated metastatic breast cancer. To improve on tolerability and handling of the regime carboplatin may be the more appropriate choice for treatment. The mechanism of action of carboplatin is very similar to that of cisplatin. The rational for combining gemcitabine and carboplatin is based on their single-agent activities in metastatic breast cancer, the activity of this combination in other malignancies and on the fact that carboplatin has demonstrated efficacy comparable with cisplatin in several tumor types.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: gemcitabine Drug: carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Adequate haematological, renal, cardiac and hepatic function:
Exclusion Criteria:
Study ID Numbers: | Gem/Carbo MUC01 |
Study First Received: | March 20, 2007 |
Last Updated: | March 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00450762 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
pretreated metastatic |
Skin Diseases Breast Neoplasms Carboplatin Gemcitabine Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |