Phase I clinical trial of weekly docetaxel and exisulind, a novel inducer of apoptosis View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2006-01-13

AUTHORS

Agustin A. Garcia, Syma Iqbal, David Quinn, Susan Edwards, Heinz Josef Lenz, Jeff Weber

ABSTRACT

Background: The objective of this phase I study was to determine the maximal tolerated dose (MTD) of the combination of weekly docetaxel and exisulind in patients with advanced solid tumors. Patients and methods: Patients with advanced or refractory solid tumors were treated with intravenous weekly docetaxel with daily oral exisulind. The following dose levels (docetaxel/exisulind) were explored: 30-mg/m2/200 mg po bid, 35/200, 35/250 and 40/250. Docetaxel was administered weekly for 6 weeks followed by 2 weeks off, and exisulind was taken twice daily. Each cycle was 8 weeks. Results: Eighteen patients were enrolled in the study. All of them had received prior systemic therapy. Most patients had either melanoma or carcinomas of the upper gastrointestinal tract. A total of 31 cycles of therapy were administered. DLTs were grade 3 diarrhea, anorexia and fatigue and grade 3 cutaneous toxicity at dose level 4 (40/250). Myelosuppression was mild. Fatigue and gastrointestinal toxicity (anorexia, dyspepsia, nausea, abdominal pain and diarrhea) represented the most common toxicities. However, grade 3 and grade 4 toxicities were uncommon. There were no treatment related deaths. No objective responses were observed and five patients achieved stable disease. Conclusions: The recommended dose for phase II studies is weekly docetaxel 35 mg/m2 for 6 weeks followed by 2 weeks off in combination with oral exisulind 250 mg po bid. This combination is feasible and well-tolerated at these doses. More... »

PAGES

79-83

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10637-005-4542-0

DOI

http://dx.doi.org/10.1007/s10637-005-4542-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1052711980

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/16379039


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