Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

NCT ID: NCT00028483

Last Updated: 2011-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2003-04-30

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.

Detailed Description

OBJECTIVES:

• Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) and docetaxel in women with metastatic or recurrent breast cancer.
• Determine the clinical response rate and duration of response of patients treated with this regimen.

OUTLINE: Patients receive doxorubicin-monoclonal antibody BR96 immunoconjugate (SGN-15) IV over 2 hours and docetaxel IV over 30 minutes on day 1 of weeks 1-6. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 18-24 months.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cBR96-doxorubicin immunoconjugate

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Lisle M. Nabell, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

SGEN-UAB-9912

Identifier Type: -

Identifier Source: secondary_id

UAB-9912

Identifier Type: -

Identifier Source: secondary_id

CDR0000069079

Identifier Type: -

Identifier Source: org_study_id