Status:
COMPLETED
Gemcitabine + Carboplatin in Breast Cancer
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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:
- Leukocyte count ≥ 3.0 x 109/l
- Absolute neutrophil count ≥ 2.0 x 109/l
- Platelet count ≥ 100 x 109/l
- Haemoglobin ≥ 8 g/dl
- Total serum bilirubin ≤ 1.25 x upper limit of normal (ULN) In presence of liver metastasis ≤ 3 x ULN
- Transaminase (ALT,AST) level ≤ 3 x ULN In presence of liver metastasis ≤ 5 x ULN
- Alkaline phosphatase level ≤ 2.5 x ULN
- Creatinine clearance was required to exceed 60 ml/min.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00450762
Start Date
March 1 2004
End Date
October 1 2006
Last Update
March 22 2007
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