Abstract | PURPOSE: EXPERIMENTAL DESIGN: Patients with at least one prior systemic therapy and a rising prostate-specific antigen (PSA) were eligible. Patients received 17-AAG at a dose of 300 mg/m2 i.v. weekly for 3 of 4 weeks. The primary objective was to assess the PSA response. Secondary objectives were to determine overall survival, to assess toxicity, and to measure interleukin-6, interleukin-8, and maspin levels and quality of life. RESULTS: Fifteen eligible patients were enrolled. The median age was 68 years and the median PSA was 261 ng/mL. Patients received 17-AAG for a median number of two cycles. Severe adverse events included grade 3 fatigue (four patients), grade 3 lymphopenia (two patients), and grade 3 back pain (two patients). The median PSA progression-free survival was 1.8 months (95% confidence interval, 1.3-3.4 months). The 6-month overall survival was 71% (95% confidence interval, 52-100%). CONCLUSIONS:
17-AAG did not show any activity with regard to PSA response. Due to insufficient PSA response, enrollment was stopped at the end of first stage per study design. The most significant severe toxicity was grade 3 fatigue. Further evaluation of 17-AAG at a dose of 300 mg/m2 i.v. weekly as a single agent in patients with metastatic, hormone-refractory prostate cancer who received at least one prior systemic therapy is not warranted.
|
Authors | Elisabeth I Heath, David W Hillman, Ulka Vaishampayan, Shijie Sheng, Fazlul Sarkar, Felicity Harper, Melvin Gaskins, Henry C Pitot, Winston Tan, S Percy Ivy, Roberto Pili, Michael A Carducci, Charles Erlichman, Glenn Liu |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 14
Issue 23
Pg. 7940-6
(Dec 01 2008)
ISSN: 1078-0432 [Print] United States |
PMID | 19047126
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antineoplastic Agents
- Benzoquinones
- Interleukin-6
- Interleukin-8
- Lactams, Macrocyclic
- SERPIN-B5
- Serpins
- tanespimycin
- Prostate-Specific Antigen
|
Topics |
- Aged
- Antineoplastic Agents
(therapeutic use)
- Benzoquinones
(therapeutic use)
- Drug Resistance, Neoplasm
- Humans
- Immunoassay
- Interleukin-6
(blood)
- Interleukin-8
(blood, drug effects)
- Kaplan-Meier Estimate
- Lactams, Macrocyclic
(therapeutic use)
- Male
- Middle Aged
- Prostate-Specific Antigen
(blood, drug effects)
- Prostatic Neoplasms
(drug therapy, mortality)
- Quality of Life
- Reverse Transcriptase Polymerase Chain Reaction
- Serpins
(biosynthesis, drug effects)
|