Gemcitabine + Carboplatin in Breast Cancer

March 21, 2007 updated by: Ludwig-Maximilians - University of Munich

Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Volker Heinemann, MD, University of Munich - Klinikum Grosshadern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 21, 2007

First Posted (Estimate)

March 22, 2007

Study Record Updates

Last Update Posted (Estimate)

March 22, 2007

Last Update Submitted That Met QC Criteria

March 21, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gem/Carbo MUC01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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