NCT00028483

Brief Summary

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 27, 2003

Completed
Last Updated

October 24, 2011

Status Verified

October 1, 2011

First QC Date

January 4, 2002

Last Update Submit

October 21, 2011

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancer

Interventions

cBR96-doxorubicin immunoconjugateDRUG
docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or recurrent breast carcinoma * Unresectable disease * Previously treated with no more than 2 chemotherapy regimens for metastatic disease OR * Recurrent within 6 months of adjuvant chemotherapy * Must have one of the following: * Measurable disease * Positive bone scan and elevation of serum tumor marker for adenocarcinoma * Serum levels must have increased over 2 consecutive measurements and exceed at least 2 times upper limit of normal * Lewis-y antigen expression documented by immunohistochemistry * No brain metastases that are uncontrolled or require active treatment (including steroids) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 10 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No bleeding diathesis Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2.5 times normal * Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis present) * Amylase/lipase less than 1.5 times normal * Hepatitis B and C negative * No hepatic failure Renal: * Creatinine no greater than 1.5 times upper limit of normal * No renal failure Cardiovascular: * LVEF greater than 50% by echocardiogram or MUGA scan * No congestive heart failure Other: * HIV negative * No antibody present that detects monoclonal antibody BR96 in serum * No peripheral neuropathy grade 2 or greater * No dementia or altered mental status * No other serious underlying medical condition that would preclude study participation * No prior allergic reactions to recombinant human or murine proteins * No uncontrolled peptic ulcer disease * No active viral, bacterial, or systemic fungal infections * No other primary malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix * No serious nonmalignant disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 8 weeks since prior therapeutic or diagnostic murine/humanized/human chimeric antibodies Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, mitomycin, or anthracyclines) * No prior cumulative anthracycline of 300 mg/m2 or more * No concurrent antineoplastic agents Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior hormonal therapy * No concurrent hormonal therapy except estrogen replacement Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics Other: * No other concurrent experimental agents * No concurrent immunosuppressive medications

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

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BR96-doxorubicin immunoconjugateDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Lisle M. Nabell, MD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2002

First Posted

June 27, 2003

Study Start

October 1, 2000

Study Completion

April 1, 2003

Last Updated

October 24, 2011

Record last verified: 2011-10

Locations

US(1)