Gemcitabine + Carboplatin in Breast Cancer

NCT00450762 | Completed Phase 2

• 1 other identifier: Gem/Carbo MUC01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Breast Cancer

Keywords

pretreated; metastatic

Interventions

gemcitabine DRUG

carboplatin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Volker Heinemann, MD

  University of Munich - Klinikum Grosshadern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: March 1, 2004
• Study Completion: October 1, 2006
• Last Updated: March 22, 2007

Record last verified: 2007-03