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Phase II clinical trial of 13-cis-retinoic acid and interferon-α-2a in patients with advanced esophageal carcinoma

✍ Scribed by Peter C. Enzinger; David H. Ilson; Leonard B. Saltz; Lisa K. Martin; David P. Kelsen


Publisher
John Wiley and Sons
Year
1999
Tongue
English
Weight
68 KB
Volume
85
Category
Article
ISSN
0008-543X

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✦ Synopsis


BACKGROUND.

Interferon in combination with 5-fluorouracil has been shown to be active in squamous cell carcinoma (SCC) and adenocarcinoma (AC) of the esophagus. 13-cis-retinoic acid (CRA) has chemopreventive activity in SCC of the head and neck, and, in combination with interferon, has antitumor activity in SCC of the skin and cervix.

METHODS.

The activity and toxicity of CRA and interferon-␣-2a (IFN) in patients with advanced esophageal carcinoma was evaluated in a Phase II single institution trial. Patients had unresectable or metastatic AC or SCC of the esophagus. One prior chemotherapy regimen was allowed. IFN was given by daily subcutaneous injection at a dose of 3 million U and CRA was taken orally at a dose of 1 mg/kg/day in 2 divided doses. Treatment was given in cycles of 4 weeks and continued until documented disease progression.


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