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A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191451
First received: September 12, 2005
Last updated: November 17, 2009
Last verified: November 2009
History of Changes
  Purpose

The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.


Condition Intervention Phase
Breast Cancer
 Drug: Gemcitabine
Drug: Carboplatin
Drug: Herceptin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Tumor Response [ Time Frame: baseline to disease progression/recurrence (up to 3.5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years) ] [ Designated as safety issue: No ]
  • Number of Patients Who Experienced Alopecia [ Time Frame: Baseline to 3.5 years ] [ Designated as safety issue: Yes ]
  • Time to Disease Progression (TTP) [ Time Frame: randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years) ] [ Designated as safety issue: No ]
  • Percentage of Patients With Overall Survival at 1 Year and 2 Years [ Time Frame: 1 Year, 2 Years ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HER2+
Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.
 Drug: Gemcitabine
Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
Other Name: Gemzar
Drug: Carboplatin
Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
Other Name: Paraplatin
Drug: Herceptin

Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion).

Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).
Experimental: HER2- (Taxane-)
Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients).
 Drug: Gemcitabine
Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
Other Name: Gemzar
Drug: Carboplatin
Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
Other Name: Paraplatin
Experimental: HER2- (Taxane+)
Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).
 Drug: Gemcitabine
Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
Other Name: Gemzar
Drug: Carboplatin
Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
Other Name: Paraplatin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of metastatic breast cancer
  2. Able to visit the doctor's office at least every 14 days during the actual treatment
  3. Able to care for yourself, even if you cannot work or participate in other normal activities
  4. Your blood results must be adequate for therapy.
  5. If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.

Exclusion Criteria:

  1. Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
  2. Be pregnant or breastfeeding
  3. Have cancer to the brain and has not been treated
  4. Have another active cancer besides breast cancer
  5. Have received stem cell or bone marrow transplant for hematologic (blood type) cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191451

Locations
United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States, 46203
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191451     History of Changes
Other Study ID Numbers: 9397, B9E-US-S359
Study First Received: September 12, 2005
Results First Received: October 12, 2009
Last Updated: November 17, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Mitogens
Gemcitabine
Trastuzumab
Carboplatin
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antimetabolites, Antineoplastic
Antimetabolites
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 May 16, 2013