PS-341 in Treating Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00028639
First received: January 4, 2002
Last updated: July 1, 2011
Last verified: July 2011
  Purpose

RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: bortezomib
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of the Proteasome Inhibitor PS-341 (NSC 681 239) in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Study Start Date: August 2001
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib.
  • Determine the toxic effects of this drug in these patients.
  • Determine the progression-free survival in patients treated with this drug.

OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
  • Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab [Herceptin]) for metastatic disease

    • Relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure
  • No known brain metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • No uncontrolled concurrent illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib
  • No other prior malignancy within the past 5 years unless curatively treated and disease free
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • Prior hormonal therapy for metastatic disease allowed
  • At least 4 weeks since prior hormonal therapy and recovered

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • Prior adjuvant therapy allowed
  • At least 4 weeks since prior investigational drugs and recovered
  • No other concurrent investigational or commercial agents or therapies for breast cancer
  • No concurrent combination antiretroviral therapy for HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028639

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: William J. Gradishar, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: William Gradishar, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00028639     History of Changes
Other Study ID Numbers: NCI 00B11, NU-NCI00B11, NCI-1862
Study First Received: January 4, 2002
Last Updated: July 1, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Northwestern University:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014