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

Breast Cancer Clinical Trial

Official title:

Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191451
• Other study ID #: 9397
• Secondary ID: B9E-US-S359
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 17, 2009
• Start date: April 2004
• Est. completion date: October 2008

Study information

• Verified date: November 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)
• Carboplatin
Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).
• 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).

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Tumor Response		baseline to disease progression/recurrence (up to 3.5 years)	No
Secondary	Duration of Response		date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)	No
Secondary	Number of Patients Who Experienced Alopecia		Baseline to 3.5 years	Yes
Secondary	Time to Disease Progression (TTP)		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)	No
Secondary	Percentage of Patients With Overall Survival at 1 Year and 2 Years		1 Year, 2 Years	No