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

Breast Cancer Clinical Trial

Official title:

A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00028483
• Other study ID #: CDR0000069079
• Secondary ID: SGEN-UAB-9912UAB
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2002
• Last updated: October 21, 2011
• Start date: October 2000
• Est. completion date: April 2003

Study information

• Verified date: October 2011
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cBR96-doxorubicin immunoconjugate

• docetaxel

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States,