A phase II study of DJ-927 as second-line therapy in patients (pts) with advanced gastric cancer (GC) who have failed a 5-FU non taxane based regimen.

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Abstracts

2006 ASCO Annual Meeting

A phase II study of DJ-927 as second-line therapy in patients (pts) with advanced gastric cancer (GC) who have failed a 5-FU non taxane based regimen.

Sub-category:

Esophageal, Gastric, or Small Bowel Cancer

Category:

Gastrointestinal (Noncolorectal) Cancer

Meeting:

2006 ASCO Annual Meeting

Session Type and Session Title:

General Poster Session, Gastrointestinal (Noncolorectal) Cancer

Abstract No:

4081

Citation:

Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 4081

Author(s):

T. Evans, R. Dobrila, R. Berardi, K. A. Sumpter, L. R. Wall, R. Oyama, D. A. Anthoney

Abstract:

Background: Most 1st-line combination chemotherapy regimens in pts with advanced GC include 5-FU. Taxanes are also active agents in GC, either alone or in combination. However, there is no recognized 2nd-line regimen for use in pts with advanced GC. DJ-927 is a semi-synthetic novel taxane with in vitro activity against GC cells lines. It is administered orally, with hematologic dose-limiting toxicity (DLT) in Phase I studies. The primary objective of this study was to determine the objective response rate of DJ-927 as 2nd-line therapy in pts with advanced GC. Methods: Eligible pts had confirmed advanced GC with no more than 1 prior systemic 5-FU-containing regimen for advanced disease, with adequate hematologic, renal and liver function, and with measurable disease. The starting dose in the 1st cohort of 6 pts was 27 mg/m² orally, every 3 weeks. If < 2 DLTs occurred at this dose, the next cohort of 6 pts would start at a dose of 35 mg/m², every 3 weeks, and all subsequent pts would be treated at the optimal dose level. Measurable disease was assessed after every 2 courses. Pharmacokinetic sampling was performed during course 1 only. Sample size based on a 3-outcome 1-stage design was calculated to be 27 pts evaluable for response, with > 4 responses of 27 pts indicating that DJ-927 has activity in advanced GC. Results: 36 pts (male=25; female = 11), KPS > 60%, with GC (n = 23) or OG junction cancer (n = 13), received 104 courses (median = 2; range 1-9) of DJ-927. 2 DLTs (febrile neutropenia; Grade 4 neutropenia > 5 days) occurred at 35 mg/m², and the optimal starting dose was confirmed as 27 mg/m². 6 of 36 pts were not evaluable for response (< 1 complete treatment course) due to early disease progression (3), toxicity (2), and drug not given (1). Response data is available for 26 of 30 evaluable pts with confirmed PR (n = 5), SD (15), and PD (6). Toxicity, > grade 3, in evaluable pts (n = 33) included neutropenia (17), anemia (5), thrombocytopenia (4), diarrhoea (7), fatigue (5), lethargy (4), neutropenic sepsis (5). Conclusions: DJ-927 has modest activity in pts with GC who have failed a 5-FU non-taxane based regimen. Toxicities include neutropenia ± sepsis, diarrhoea and lethargy. Further studies of DJ-927 in combination with other active agents are warranted in pts with GC.

Associated Presentation(s):

1. A phase II study of DJ-927 as second-line therapy in patients (pts) with advanced gastric cancer (GC) who have failed a 5-FU non taxane based regimen.

Meeting: 2006 ASCO Annual Meeting
Presenter: T R Jeffry Evans
Session: Gastrointestinal (Noncolorectal) Cancer (General Poster Session)

Other Abstracts in this Sub-Category:

		1. Superiority of trimodality therapy to surgery alone in esophageal cancer: Results of CALGB 9781. Meeting: 2006 ASCO Annual Meeting Abstract No: 4012 First Author: J. E. Tepper Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal, Gastric, or Small Bowel Cancer
		2. A randomized clinical study of surgery versus radiotherapy in the treatment of resectable esophageal cancer. Meeting: 2006 ASCO Annual Meeting Abstract No: 4013 First Author: J. Yu Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal, Gastric, or Small Bowel Cancer
		3. Surgery plus ELFE (epirubicin, leucovorin, 5-fluorouracil and etoposide) vs surgery alone in radically resected gastric cancer (GC): Final results of a randomised phase III trial by the Gruppo Oncologico dell' Italia Meridionale (GOIM). Meeting: 2006 ASCO Annual Meeting Abstract No: 4014 First Author: F. De Vita Category: Gastrointestinal (Noncolorectal) Cancer - Esophageal, Gastric, or Small Bowel Cancer
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Abstracts by T. Evans:

		1. Phase I dose-escalation study of continuous oral dosing of OSI-906, a dual tyrosine kinase inhibitor of insulin-like growth factor-1 receptor (IGF-1R) and insulin receptor (IR), in patients with advanced solid tumors. Meeting: 2010 ASCO Annual Meeting Abstract No: 2531 First Author: T. Evans Category: Developmental Therapeutics - Clinical Pharmacology and Immunotherapy - Phase I Studies
		2. Clinical outcomes of elective nodal irradiation (ENI) compared with involved field radiotherapy (IFRT) in NSCLC. Meeting: 2009 ASCO Annual Meeting Abstract No: 7541 First Author: A. Fernandes Category: Lung Cancer--Local-Regional and Adjuvant Therapy - Local-Regional Therapy
		3. Phase II trial of oral imatinib in combination with every-three-week intravenous docetaxel in patients with metastatic, hormone- refractory prostate cancer: An update. Meeting: 2008 Genitourinary Cancers Symposium Abstract No: 259 First Author: L. J. Appleman Category: Genitourinary Cancers - Prostate
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Presentations by T. Evans:

		1. Phase I dose-escalation study of continuous oral dosing of OSI-906, a dual tyrosine kinase inhibitor of insulin-like growth factor-1 receptor (IGF-1R) and insulin receptor (IR), in patients with advanced solid tumors. Meeting: 2010 ASCO Annual Meeting Presenter: T.R. Jeffry Evans Session: Developmental Therapeutics - Clinical Pharmacology and Immunotherapy (Poster Discussion Session)
		2. 5-year outcome for women randomised in a phase III trial comparing doxorubicin (A) and cyclophosphamide (C) with doxorubicin and docetaxel (D) as primary medical therapy of breast cancer: An Anglo-Celtic Cooperative Oncology Group Study. Meeting: 2008 ASCO Annual Meeting Presenter: T.R. Jeffry Evans, MD, FRCP Session: Breast Cancer — Local-Regional and Adjuvant Therapy (General Poster Session)
		3. Interim results from a phase II study of volociximab in combination with gemcitabine (GEM) in patients (pts) with metastatic pancreatic cancer (MPC) Meeting: 2008 Gastrointestinal Cancers Symposium Presenter: T.R. Jeffry Evans, MD Session: General Poster Session B (Poster Presentation)
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Educational Book Manuscripts by T. Evans:

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