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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.
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096109
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: tanespimycin
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: IPI-504 17-(Allylamino)-17-demethoxygeldanamycin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Clinical Trial Of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) In Chemotherapy Refractory Metastatic Breast Cancer

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

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 37
Study Start Date: September 2004
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096109

Locations
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96913
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Weisberg Cancer Treatment Center
Detroit, Michigan, United States, 48334
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Elaina M. Gartner, MD Barbara Ann Karmanos Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000391198, WSU-C-2803, NCI-6552
Study First Received: November 9, 2004
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00096109  
Health Authority: United States: Federal Government

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

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009