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Sub-category:
Ovarian Cancer
Category:
Gynecologic Cancer
Meeting:
2008 ASCO Annual Meeting
Session Type and Session Title:
General Poster Session, Gynecologic Cancer
Abstract No:
5593
Citation:
J Clin Oncol 26: 2008 (May 20 suppl; abstr 5593)
Author(s):
C. N. Krasner, M. V. Seiden, R. T. Penson, M. Roche, D. L. Kendall, J. Young, U. A. Matulonis, L. Pereira, S. T. Berlin
Abstract:
Background: Platinum remains the single most effective drug for the treatment of epithelial ovarian cancer; however with relapse and re-treatment most patients eventually become resistant to these drugs. Response rates to salvage chemotherapy in this population is 10-20%, with PFS typically < 8 weeks in 4th line. One mechanism of platinum resistance is thought to be mediated by changes in the cellular redox potential. Oxidized glutathione (GSSG), the active component of NOV-002, regulates the intracellular redox state via the glutathione (GSH) pathway. This study aims to determine tolerabilty, response rate and PFS to NOV-002 with carboplatin in women with platinum resistant ovarian, tubal or peritoneal cancer. Methods: NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles. Patients must be platinum refractory/resistant, with measurable disease and < 3 prior lines. Fifteen patients are accrued in the first stage of the trial; if > 2 responses, 10 additional patients will be accrued. Results: Stage I accrual is complete. Patients were heavily pretreated with 11/15 having received 3 prior lines. Toxicity was mild-moderate with no grade 4 toxicity. There was no febrile neutropenia. The most common toxicities were nausea and fatigue, as well as abdominal pain and bowel obstruction thought to be related to underlying disease. To date, there is 1 PR, 7 SD and 5 PD, with 1 patient off-trial for patient discretion. PFS is 14 weeks. Treatment and evaluation are ongoing, with the possibility of accrual to the second stage if another PR is seen. Conclusions: Patients tolerated this regimen extremely well, with most toxicity attributable to carboplatin alone. The PFS was longer than expected, with a significant proportion of these platinum resistant patients achieving clinical benefit with prolonged stable disease. Updated results will be available.
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by C. N. Krasner :
Presentations by C. N. Krasner :
Educational Book Manuscripts by C. N. Krasner :
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