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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lisle M. Nabell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069079

NCT ID:

NCT00028483

Start Date:

October 2000

Completion Date:

April 2003

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300