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17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer
This study has been completed.

First Received on November 9, 2004.   Last Updated on April 13, 2010   History of Changes
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborator: 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) In Chemotherapy Refractory Metastatic Breast Cancer

Resource links provided by NLM:


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
Primary Completion Date: November 2009 (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

Additional Information:
No publications provided

Responsible Party: Patricia M. LoRusso, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00096109     History of Changes
Other Study ID Numbers: CDR0000391198, WSU-C-2803, NCI-6552
Study First Received: November 9, 2004
Last Updated: April 13, 2010
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

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

ClinicalTrials.gov processed this record on February 12, 2012