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

NCT00118092 | Completed Phase 2 Results

• 7 other identifiers: NCI-2012-01466MAYO-MC0453NCI-6651CDR0000433492MC04536651N01CM62205
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group

  Normalization: PSA ≤4.0 ng/ml. This must be confirmed by a second PSA value measured when patient returns in 4-6 weeks. This qualifies as a CR response. \> \> 50% decline: A 50% decline in PSA value from baseline which must be confirmed by a second PSA value measured when patient returns in 4-6 weeks later. This qualifies as a PR response.\> \> Progression: A 25% or greater increase over baseline and an increase in the PSA level by at least 5 ng/mL, which is confirmed by a second value obtained approximately one week later. In addition, radiographic scans are required to confirm that a disease progression is by PSA only.

  Up to 1 year

Secondary Outcomes (4)

• Proportion of Overall Responses

  Up to 3 years

• Overall Survival

  From registration to death due to any cause, assessed up to 3 years

• Disease-free Survival

  From registration to documentation of disease progression, assessed up to 3 years

• Duration of PSA Response and PSA Control

  From PSA response to time of progression, assessed up to 1 year

Study Arms (1)

Treatment (tanespimycin)

EXPERIMENTAL

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.

Drug: tanespimycin; Other: laboratory biomarker analysis

Interventions

tanespimycin DRUG

Given IV

Treatment (tanespimycin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (tanespimycin)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Elisabeth Iljas Heath, M.D.
• Organization: Karmanos Cancer Institute at Wayne State University

heathe@karmanos.org

Study Officials

• Elisabeth Heath

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: January 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: February 1, 2008
• Last Updated: April 18, 2017
• Results First Posted: February 20, 2017

Record last verified: 2017-03

Locations

US (1)