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17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00096109   Information provided by National Cancer Institute (NCI)
First Received: November 9, 2004   Last Updated: April 14, 2009   History of Changes

November 9, 2004
April 14, 2009
September 2004
January 2008   (final data collection date for primary outcome measure)
  • Response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Correlation of HER2/neu status with response [ Designated as safety issue: No ]
  • Response rate
  • Progression-free survival
  • Correlation of HER2/neu status with response
Complete list of historical versions of study NCT00096109 on ClinicalTrials.gov Archive Site
 
 
 
17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
A Phase II Clinical Trial Of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) In Chemotherapy Refractory Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well 17-AAG works in treating women with refractory locally advanced or metastatic breast cancer.

OBJECTIVES:

  • Determine the response rate in women with refractory locally advanced or metastatic primary adenocarcinoma of the breast treated with 17-N-allylamino-17-demethoxygeldanamycin.
  • Determine the progression-free survival of patients treated with this drug.
  • Correlate HER2/neu status with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive 17-N-allylamino-17-demethoxygeldanamycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at day 30, every 10-12 weeks until disease progression, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 14 months.

Phase II
Interventional
Treatment, Open Label
Breast Cancer
Drug: tanespimycin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
37
 
January 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary adenocarcinoma of the breast

    • Locally advanced or metastatic disease
  • At least 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by MRI or spiral CT scan

    • Outside prior irradiation field
  • Disease progression after prior hormonal therapy in estrogen receptor (ER)-positive and/or indolent disease
  • Disease progression after prior treatment with OR contraindication to an anthracycline and a taxane-based regimen (as adjuvant therapy or for metastatic disease)
  • Not amenable to curative surgery or radiotherapy
  • No known brain or leptomeningeal metastases requiring active therapy

    • Asymptomatic previously treated metastases allowed
  • Hormone receptor status:

    • ER status known

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Sex

  • Female

Menopausal status

  • Premenopausal or postmenopausal

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 1.5 times ULN (3 times ULN if liver metastases are present)

Renal

  • Creatinine ≤ ULN OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • QTc ≤ 450 msec for men (470 msec for women)
  • LVEF ≥ 40% by MUGA
  • Deep venous thrombosis or other clinically significant thromboembolic event within the past 6 months allowed provided patient is clinically stable on anticoagulation therapy
  • No New York Heart Association class III or IV heart failure
  • No myocardial infarction within the past year
  • No active ischemic heart disease within the past year
  • No history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs
  • No congenital long QT syndrome
  • No left bundle branch block
  • No poorly controlled angina
  • No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No severe or unstable angina within the past 6 months
  • No symptomatic congestive heart failure within the past 6 months
  • No cerebrovascular accident or transient ischemic attack within the past 6 months

Pulmonary

  • Pulmonary embolus within the past 6 months allowed provided patient is clinically stable on anticoagulation therapy
  • No symptomatic pulmonary disease including any of the following:

    • Dyspnea
    • Chronic obstructive pulmonary disease
    • Restrictive lung disease
  • No oxygen requirement

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 2 weeks after study participation
  • No serious allergy to eggs (e.g., hypotension, dyspnea, anaphylaxis, or edema)
  • No known HIV positivity
  • No other active infection
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent trastuzumab (Herceptin^®)

Chemotherapy

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

Endocrine therapy

  • See Disease Characteristics
  • At least 2 weeks since prior hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • More than 2 weeks since prior radiotherapy
  • No prior radiotherapy that potentially included the heart in the field (e.g., mantle)
  • No prior radiotherapy to the chest

Surgery

  • More than 4 weeks since prior surgery
  • More than 6 months since prior coronary or peripheral artery bypass grafting

Other

  • Concurrent zoledronate for bone metastases or hypercalcemia allowed
  • No concurrent medications that prolong or may prolong QTc interval
  • No other concurrent antineoplastic agents
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00096109
Patricia M. LoRusso, Barbara Ann Karmanos Cancer Institute
CDR0000391198, WSU-C-2803, NCI-6552
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Elaina M. Gartner, MD Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP