Combination Chemotherapy for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191815
First received: September 12, 2005
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer


Condition Intervention Phase
Breast Cancer
Drug: Gemcitabine
Drug: cisplatin
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: Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Objective Tumor Response [ Time Frame: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Time to Progressive Disease [ Time Frame: first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Survival Time [ Time Frame: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: No ]
  • Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination [ Time Frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) ] [ Designated as safety issue: Yes ]
  • Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades [ Time Frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) ] [ Designated as safety issue: Yes ]
  • Number of Deaths [ Time Frame: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ] [ Designated as safety issue: Yes ]
  • Number of Participants With Adverse Events Leading to Discontinuation [ Time Frame: Baseline through eight 21-day cycles ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: October 2002
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: Gemcitabine + Cisplatin Drug: Gemcitabine
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Drug: cisplatin
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You are female in the age of 18 to 75 years old.
  • You have been diagnosed with the metastatic breast cancer.
  • You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
  • You must sign this informed consent form

Exclusion Criteria:

  • You are pregnant or breastfeeding.
  • Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
  • You have been diagnosed with serious concomitant or acute infectious disease.
  • You have used experimental medications within the last month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191815

Locations
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician
Munich, Germany, 81377
Russian Federation
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician
Moscow, Russian Federation, 115478
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00191815     History of Changes
Other Study ID Numbers: 7311, B9E-VI-S326
Study First Received: September 12, 2005
Results First Received: October 13, 2008
Last Updated: November 9, 2009
Health Authority: Russia: Pharmacological Committee, Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 21, 2014