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
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: 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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014