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Gemcitabine + Carboplatin in Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00450762
First received: March 20, 2007
Last updated: March 21, 2007
Last verified: March 2007
  Purpose

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
Breast Cancer
Drug: gemcitabine
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer

Resource links provided by NLM:


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

Study Start Date: March 2004
Estimated Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic breast cancer
  • All patients were required to give written informed consent.
  • Prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
  • Patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
  • Age ≥ 18 years
  • Karnofsky Performance status ≥ 70 %
  • Minimal life expectancy of 12 weeks
  • Adequate haematological, renal, cardiac and hepatic function:

    1. Leukocyte count ≥ 3.0 x 109/l
    2. Absolute neutrophil count ≥ 2.0 x 109/l
    3. Platelet count ≥ 100 x 109/l
    4. Haemoglobin ≥ 8 g/dl
    5. Total serum bilirubin ≤ 1.25 x upper limit of normal (ULN) In presence of liver metastasis ≤ 3 x ULN
    6. Transaminase (ALT,AST) level ≤ 3 x ULN In presence of liver metastasis ≤ 5 x ULN
    7. Alkaline phosphatase level ≤ 2.5 x ULN
    8. Creatinine clearance was required to exceed 60 ml/min.

Exclusion Criteria:

  • Prior treatment with gemcitabine or platinum agents
  • Inadequate creatinine clearance (< 60 ml/min)
  • Only bone metastases
  • Symptomatic brain metastases
  • Women who are pregnant, lactating or refuse effective contraception
  • Secondary malignancy
  • History of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
  • Active infection
  • Any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450762

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Eli Lilly and Company
Investigators
Principal Investigator: Volker Heinemann, MD University of Munich - Klinikum Grosshadern
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00450762     History of Changes
Other Study ID Numbers: Gem/Carbo MUC01
Study First Received: March 20, 2007
Last Updated: March 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
pretreated
metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014