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

NCT00191451 | Completed Phase 2 Results

• 2 other identifiers: 9397B9E-US-S359
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Tumor Response

  Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

  baseline to disease progression/recurrence (up to 3.5 years)

Secondary Outcomes (4)

• 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)

• Number of Patients Who Experienced Alopecia

  Baseline to 3.5 years

• 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)

• Percentage of Patients With Overall Survival at 1 Year and 2 Years

  1 Year, 2 Years

Study Arms (3)

HER2+

EXPERIMENTAL

Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.

Drug: Gemcitabine; Drug: Carboplatin; Drug: Herceptin

HER2- (Taxane-)

EXPERIMENTAL

Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients).

Drug: Gemcitabine; Drug: Carboplatin

HER2- (Taxane+)

EXPERIMENTAL

Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).

Drug: Gemcitabine; Drug: Carboplatin

Interventions

Gemcitabine DRUG

Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion)

Also known as: Gemzar

HER2+; HER2- (Taxane+); HER2- (Taxane-)

Carboplatin DRUG

Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).

Also known as: Paraplatin

HER2+; HER2- (Taxane+); HER2- (Taxane-)

Herceptin DRUG

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).

HER2+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metastatic breast cancer
• Able to visit the doctor's office at least every 14 days during the actual treatment
• Able to care for yourself, even if you cannot work or participate in other normal activities
• Your blood results must be adequate for therapy.
• 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.

You may not qualify if:

• Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
• Be pregnant or breastfeeding
• Have cancer to the brain and has not been treated
• Have another active cancer besides breast cancer
• Have received stem cell or bone marrow transplant for hematologic (blood type) cancer

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 46203, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Carboplatin; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 20, 2009
• Results First Posted: November 17, 2009

Record last verified: 2009-11

Locations

US (1)