Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer

NCT00006104 | Completed Phase 2 DMC

• 4 other identifiers: VICC BRE 9823P30CA068485VU-VCC-BRE-9823NCI-G00-1830
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 15

Brief Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

trastuzumab BIOLOGICAL

docetaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancer HER2-neu overexpressing tumor (2+ or 3+) Measurable or evaluable disease If bone disease only, must have lytic lesions No carcinomatous meningitis or untreated or uncontrolled brain parenchymal disease Prior brain parenchymal disease allowed if controlled by appropriate therapy given at least 8 weeks prior to study, and patient is asymptomatic from CNS disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure Ejection fraction greater than 45% by MUGA No myocardial infarction within the past 6 months No ischemic heart disease requiring medication No uncontrolled hypertension Other: No peripheral neuropathy grade 2 or more No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral breast cancer No active unresolved infection No history of hypersensitivity reaction to products containing Polysorbate 80 No poorly controlled diabetes mellitus Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers Chemotherapy: Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic disease No prior taxane (docetaxel or paclitaxel) Prior doxorubicin allowed if total dose less than 250 mg/m2 No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior cumulative radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: At least 7 days since prior antibiotics No other concurrent investigational drugs No other concurrent antineoplastic therapy No concurrent parenteral antibiotics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

Providence Hospital

Mobile, Alabama, 36608, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Owensboro Medical Health System

Owensboro, Kentucky, 42303, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Erlanger Health Systems

Chattanooga, Tennessee, 37403, United States

Location

Memorial Health Care System

Chattanooga, Tennessee, 37404, United States

Location

Williamson Medical Center

Franklin, Tennessee, 37067, United States

Location

Jackson-Madison County Hospital

Jackson, Tennessee, 38301, United States

Location

Methodist/Thompson Oncology Research

Knoxville, Tennessee, 37916, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37920, United States

Location

Boston Baskin Cancer Group

Memphis, Tennessee, 38104, United States

Location

St. Thomas Health Services

Nashville, Tennessee, 37205, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Methodist Medical Center of Oak Ridge

Oak Ridge, Tennessee, 37831, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ingrid Mayer, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: December 24, 2003
• Study Start: September 1, 1998
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

US (15)