Combination Chemotherapy for Metastatic Breast Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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 June 17, 2013