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

• Status: Terminated
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies, Monoclonal; Docetaxel; Doxorubicin; Immunoconjugates; Liposomal doxorubicin

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