Expired Study
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Rochester, Minnesota 55905


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. 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.


Study summary:

PRIMARY OBJECTIVES: I. 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 OBJECTIVES: I. Determine the overall survival and disease-free survival rate in patients treated with this drug. II. Determine the safety profile of this drug in these patients. III. Determine the duration of PSA response and PSA control in patients treated with this drug. IV. Determine the partial and complete response rates in patients with measurable disease treated with this drug. V. 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.


Criteria:

Inclusion Criteria: - 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 - Performance status - ECOG 0-2 - At least 12 weeks - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal - Alkaline phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal - Creatinine clearance ≥ 60 mL/min - Creatinine normal - 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 embolus allowed within the past 6 months provided patient is clinically stable on anticoagulation therapy - 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 - At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) - At least 28 days since prior radiotherapy - No prior radiotherapy field that included the heart (e.g., mantle) - More than 6 months since prior coronary or peripheral artery bypass grafting - 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


Study is Available At:


Original ID:

NCI-2012-01466


NCT ID:

NCT00118092


Secondary ID:

NCI-2012-01466


Study Acronym:


Brief Title:

17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy


Official Title:

A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Hormone-Refractory Metastatic Prostate Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

28


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Elisabeth Heath
Principal Investigator
Mayo Clinic

Study Dates

Start Date:January 2005
Primary Completion Date:May 2006
Primary Completion Type:Actual
Verification Date:October 2013
Last Changed Date:October 7, 2013
First Received Date:July 8, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame:Up to 30 days after completion of treatment
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Correlation of biomarkers with cancer and treatment-related outcomes
Time Frame:Up to 3 years
Safety Issues:False
Description:Relationships will also be explored graphically using scatter plots.
Outcome Type:Secondary Outcome
Measure:Change in expression levels of interleukin-6 (IL-6), maspin and NF-kappaB
Time Frame:From baseline to up to 3 years
Safety Issues:False
Description:Summarized descriptively both quantitatively and graphically. Each of these correlative endpoints will be summarized individually, but will also be evaluated in terms of their relationships to one another; i.e. using Spearman rank correlation coefficient
Outcome Type:Secondary Outcome
Measure:Duration of PSA response and PSA control
Time Frame:From PSA response to time of progression, assessed up to 1 year
Safety Issues:False
Description:The distribution of this response duration will be estimated using the method of Kaplan-Meier.
Outcome Type:Secondary Outcome
Measure:Clinical or radiographic response rate (partial response [PR] and complete response [CR]) as measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame:Up to 3 years
Safety Issues:False
Description:The number of patients with a PR or CR will be divided by the total number of evaluable patients with measurable disease. Assuming that this response incidence is binomially distributed, exact 95% confidence intervals will also be calculated.
Outcome Type:Secondary Outcome
Measure:Disease-free survival
Time Frame:From registration to documentation of disease progression, assessed up to 3 years
Safety Issues:False
Description:The distribution of disease-free survival time will be estimated using the method of Kaplan-Meier.
Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:From registration to death due to any cause, assessed up to 3 years
Safety Issues:False
Description:The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome Type:Primary Outcome
Measure:Proportion of overall responses
Time Frame:Up to 3 years
Safety Issues:False
Description:The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and
Outcome Type:Primary Outcome
Measure:PSA response as defined by the recommendations of the Prostate-Specific Antigen Working Group
Time Frame:Up to 1 year
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:tanespimycin
Description:Given IV
Arm Name:Treatment (tanespimycin)
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (tanespimycin)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (tanespimycin)
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Heath EI, Hillman DW, Vaishampayan U, Sheng S, Sarkar F, Harper F, Gaskins M, Pitot HC, Tan W, Ivy SP, Pili R, Carducci MA, Erlichman C, Liu G. A phase II trial of 17-allylamino-17-demethoxygeldanamycin in patients with hormone-refractory metastatic prostate cancer. Clin Cancer Res. 2008 Dec 1;14(23):7940-6.
PMID:19047126

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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