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17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
This study is ongoing, but not recruiting participants.
First Received: July 8, 2005   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118092
  Purpose

RATIONALE: Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with metastatic prostate cancer that did not respond to previous hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: tanespimycin
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: 17-(Allylamino)-17-demethoxygeldanamycin IPI-504
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) In Patients With Hormone-Refractory Metastatic Prostate Cancer

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

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) level response from baseline measured ≤ 7 days prior to study and then 4-6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival from time of registration to time of death [ Designated as safety issue: No ]
  • Disease-free survival from time of registration to documentation of disease progression [ Designated as safety issue: No ]
  • Safety profile as measured by occurrence of toxicity from registration until within 30 days of completion of treatment [ Designated as safety issue: Yes ]
  • Duration of PSA response and PSA control as measured by PSA level from time of documented PSA response or control until response changes [ Designated as safety issue: No ]
  • Partial and complete response rates as measured by RECIST every 8 weeks [ Designated as safety issue: No ]
  • Correlation of changes in expression levels of interleukin-6 (IL-6), maspin and NF-kappaB in serum and tissue at baseline, day 15, and at time of treatment failure [ Designated as safety issue: No ]
  • Correlation of biomarkers with cancer and treatment-related outcomes by expression levels of IL-6, maspin, and NF-kappaB in serum and tissue at baseline, day 15, and at time of treatment failure [ Designated as safety issue: No ]

Study Start Date: August 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the prostate-specific antigen (PSA) response in patients with hormone-refractory metastatic prostate cancer treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

Secondary

  • Determine the overall survival and disease-free survival rate in patients treated with this drug.
  • Determine the safety profile of this drug in these patients.
  • Determine the duration of PSA response and PSA control in patients treated with this drug.
  • Determine the partial and complete response rates in patients with measurable disease treated with this drug.
  • Correlate changes in expression levels of interleukin-6, maspin, and NF-kappaB in serum and tissue with cancer and treatment-related outcomes in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses of treatment beyond documentation of CR.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 20 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic disease
  • Measurable or evaluable disease

    • Prostate-specific antigen (PSA) ≥ 5 ng/mL OR new areas of bony metastases on bone scan are required for patients with no measurable disease
  • Objective disease progression OR rising PSA despite receiving androgen deprivation therapy and undergoing antiandrogen withdrawal

    • Patients with a rising PSA must have 2 successive elevations (measured ≥ 1 week apart)
  • Must be castrate (testosterone < 50 ng/mL)

    • Luteinizing hormone-releasing hormone agonist therapy must be continued during study participation to maintain castrate levels of testosterone
  • Must have received ≥ 1 prior chemotherapy regimen for metastatic disease
  • No known brain metastases requiring active therapy

    • Previously treated asymptomatic brain metastases allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal OR
  • Alkaline phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal

Renal

  • Creatinine clearance ≥ 60 mL/min OR
  • Creatinine normal

Cardiovascular

  • QTc < 450 msec for male patients
  • LVEF > 40% by MUGA
  • EF normal by MUGA if prior anthracycline therapy
  • No congenital long QT syndrome
  • No left bundle branch block
  • Deep venous thrombosis or other clinically significant thromboembolic event within the past 6 months allowed provided patient is clinically stable on anticoagulation therapy
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No myocardial infarction within the past year
  • No cerebrovascular accident or transient ischemic attack within the past 6 months
  • No New York Heart Association class III or IV congestive heart failure
  • No poorly controlled angina
  • No uncontrolled dysrhythmia or dysrhythmias requiring medication
  • No active ischemic heart disease within the past 12 months
  • No other significant cardiac disease

Pulmonary

  • Pulmonary embolus allowed within the past 6 months provided patient is clinically stable on anticoagulation therapy

Other

  • Fertile patients must use effective contraception
  • Willing and able to provide blood samples
  • No serious allergy (i.e., hypotension, dyspnea, anaphylaxis, or edema) to eggs
  • No other concurrent malignancy or history of a curatively treated malignancy with a survival prognosis of < 5 years
  • No known HIV positivity
  • No active infection
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide)

Radiotherapy

  • At least 28 days since prior radiotherapy
  • No prior radiotherapy field that included the heart (e.g., mantle)

Surgery

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

Other

  • More than 28 days since prior investigational agents for prostate cancer
  • No concurrent agents that interact with cytochrome P450 3A4
  • No concurrent warfarin for anticoagulation

    • Concurrent low molecular weight heparin injection allowed
  • No concurrent medications that would prolong QTc
  • No other concurrent antineoplastic agents
  • Concurrent zoledronate for bone metastases or hypercalcemia allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118092

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Howard University Cancer Center at Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Elisabeth I. Heath, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000433492, MAYO-MC0453, NCI-6651
Study First Received: July 8, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00118092     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
adenocarcinoma of the prostate
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Hormones
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009