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Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: May 30, 2009   History of Changes
Sponsor: Seattle Genetics, Inc.
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028483
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: cBR96-doxorubicin immunoconjugate
Drug: docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028483

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Chair: Lisle M. Nabell, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069079, SGEN-UAB-9912, UAB-9912
Study First Received: January 4, 2002
Last Updated: May 30, 2009
ClinicalTrials.gov Identifier: NCT00028483     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Immunologic Factors
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Antibiotics, Antineoplastic
Doxorubicin
Pharmacologic Actions
Docetaxel
Antibodies, Monoclonal
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases
Immunoconjugates

ClinicalTrials.gov processed this record on November 09, 2009