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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00028483
Enrollment
Unknown
Registered
2003-06-27
Start date
2000-10-31
Completion date
2003-04-30
Last updated
2011-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

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.

Interventions

DRUGcBR96-doxorubicin immunoconjugate
DRUGdocetaxel

Sponsors

Seagen Inc.
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026