title: Oral indomethacin and ranitidine in advanced melanoma: a phase II study.
abstract: As a result of preclinical data demonstrating the antitumour and antimetastatic efficiency of indomethacin in murine models, and the clinical observation of occasional tumour regression in patients with advanced melanoma treated with indomethacin together with ranitidine, a Phase II study was performed of prolonged administration of these two oral agents in combination. Seventeen patients were entered into the study and commenced on indomethacin 50 mg three times daily; the dose was escalated to a maximum of 75 mg three times daily in patients who tolerated the starting dose. Ranitidine was administered concurrently at a dose of 150 mg twice daily. One patient with uveal melanoma metastatic to the liver achieved a partial response, with slow shrinkage of a biopsy-proved liver metastasis (objective response rate 6 percent; 95 percent CI0-29). Another patient demonstrated a minor response in pelvic lymph nodes. The combination of indomethacin and ranitidine has negligible activity in advanced malignant melanoma; a response may require months to be achieved.
authors.affiliation: University of Western Ontario, London, Ontario, Canada.
authors.forename: W C
authors.initials: WC
authors.lastname: Mertens
authors.forename: R C
authors.initials: RC
authors.lastname: Lohmann
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006635:Histamine H2 Antagonists / Q000008:administration & dosage*; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage*; D008113:Liver Neoplasms / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D008875:Middle Aged; D010388:Pelvis; D011899:Ranitidine / Q000008:administration & dosage*; D012074:Remission Induction; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014604:Uveal Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D006635:Histamine H2 Antagonists; D011899:Ranitidine; D007213:Indomethacin