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PS-341 in Treating Women With Metastatic Breast Cancer
This study has been completed.
First Received: October 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025584
  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 II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial Of PS-341 In Metastatic Breast Cancer

Resource links provided by NLM:


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

Study Start Date: August 2001
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer.
  • Determine the clinical activity of this drug, in terms of progression-free survival, in these women.
  • Determine the toxicity profile and tolerability of this drug in these women.
  • Determine the pharmacodynamics of this drug in these women.

OUTLINE: Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed invasive breast cancer

    • Clinical and/or radiological evidence of stage IV disease
  • Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel for advanced disease or in the adjuvant setting
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • No bone metastases as only measurable site
    • Pleural or peritoneal effusions not acceptable as measurable disease
  • No known brain metastases
  • Hormone receptor status:

    • Estrogen receptor-negative OR
    • Estrogen receptor-positive

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2
  • Karnofsky 60-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

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

Hepatic:

  • Bilirubin normal
  • AST or ALT no greater than 2.5 times upper limit of normal

Renal:

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

Cardiovascular:

  • No acute ischemia or significant conduction abnormality by EKG
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • LVEF greater than 50%

Other:

  • No uncontrolled concurrent illness
  • No psychiatric illness or social situation that would preclude study
  • No ongoing or active infection
  • No prior allergic reaction(s) to compounds of similar chemical or biologic composition to PS-341
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier-method contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Chemotherapy

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen for metastatic disease

    • High-dose regimen or bone marrow transplantation considered 1 prior regimen
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • Prior hormonal therapy for metastatic disease or in adjuvant setting allowed

Radiotherapy:

  • Prior localized radiotherapy allowed if it does not influence the signal evaluable lesion
  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • At least 2 weeks since prior minor surgery and recovered
  • At least 4 weeks since prior major surgery and recovered

Other:

  • No other concurrent investigational agent
  • No other concurrent investigational or commercial agents or therapies to treat this malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025584

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Massimo Cristofanilli, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068976, MDA-ID-00308, NCI-1855
Study First Received: October 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00025584     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Skin Diseases
Bortezomib
Breast Neoplasms
Breast Diseases
Recurrence
Protease Inhibitors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Bortezomib
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Breast Diseases
Protease Inhibitors

ClinicalTrials.gov processed this record on September 02, 2009