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Phase II Trial Of PS-341 In Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

Phase II Trial Of PS-341 In Metastatic Breast Cancer


PRIMARY OBJECTIVES:

I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic
breast cancer.

SECONDARY OBJECTIVES:

I. Determine the clinical activity of this drug, in terms of progression-free survival, in
these women.

II. Determine the toxicity profile and tolerability of this drug in these women.

III. 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.


Inclusion Criteria:



- 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
foradvanced disease or in the adjuvant setting

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques

- 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

- Estrogen receptor-positive

- Female

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- More than 12 weeks

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin normal

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

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- 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%

- 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

- See 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

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

- Prior localized radiotherapy allowed if it does not influence the signal evaluable
lesion

- At least 4 weeks since prior radiotherapy and recovered

- At least 2 weeks since prior minor surgery and recovered

- At least 4 weeks since prior major surgery and recovered

- No other concurrent investigational agent

- No other concurrent investigational or commercial agents or therapies to treat this
malignancy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response (CR + PR)

Outcome Description:

The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Principal Investigator

Massimo Cristofanilli

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02422

NCT ID:

NCT00025584

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030