Temozolomide plus thalidomide in patients with advanced melanoma: Results of a dose-finding trial Journal Article
| Authors: | Hwu, W. J.; Krown, S. E.; Panageas, K. S.; Menell, J. H.; Chapman, P. B.; Livingston, P. O.; Williams, L. J.; Quinn, C. J.; Houghton, A. N. |
| Article Title: | Temozolomide plus thalidomide in patients with advanced melanoma: Results of a dose-finding trial |
| Abstract: | Purpose: To establish a safe and tolerated regimen of an oral cytotoxic agent, temozolomide, and a cytostatic agent, thalidomide, in patients with unresectable stage III or IV malignant melanoma. Patients and Methods: Patients with unresectable stage III or IV melanoma without brain metastases were entered successively onto four treatment cohorts: level 1, temozolomide 50 mg/m2/d for 6 weeks followed by a 4-week break; levels 2, 3, and 4, temozolomide 75 mg/m2/d for 6 weeks followed, respectively, by breaks of 4, 3, and 2 weeks. Thalidomide was started at 200 mg/d, and escalated to a maximum dose of 400 mg/d. Safety was assessed at weeks 2 and 4 and every 4 weeks thereafter; tumor response was evaluated every 8 to 10 weeks. Results: Twelve patients were enrolled, three on each cohort. Therapy was generally well tolerated on all of the treatment schedules. Thalidomide at a dose of 400 mg/d was well tolerated in patients younger than 70, and 200 mg/d was well tolerated in older patients. The most common adverse events were grade 2 or 3 constipation and neuropathy, which were attributed to thalidomide. Five major responses (one complete, four partial) were documented, all at dose levels 2 to 4. Three of the five responding patients were in the over-70 age group. The median duration of response was 6 months (range, 4 to 17+ months), and the median overall survival was 12.3 months (range, 4 to 19+ months). Conclusion: The combination of temozolomide and thalidomide was well tolerated and had antitumor activity in patients with advanced melanoma, including elderly patients over 70 years old. © 2002 by American Society of Clinical Oncology. |
| Keywords: | adult; cancer survival; clinical article; controlled study; treatment outcome; aged; middle aged; survival rate; thalidomide; clinical trial; constipation; drug tolerability; fatigue; advanced cancer; diarrhea; drug safety; temozolomide; neurotoxicity; dacarbazine; melanoma; controlled clinical trial; leukopenia; neuropathy; antineoplastic combined chemotherapy protocols; deep vein thrombosis; antineoplastic activity; cytotoxicity; dose-response relationship, drug; abdominal pain; arthralgia; dyspnea; rash; brain metastasis; nausea and vomiting; headache; maximum tolerated dose; dry skin; dose calculation; visual impairment; cytostasis; humans; human; male; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 20 |
| Issue: | 11 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2002-06-01 |
| Start Page: | 2610 |
| End Page: | 2615 |
| Language: | English |
| DOI: | 10.1200/jco.2002.09.034 |
| PUBMED: | 12039921 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 14 November 2014 -- Source: Scopus |
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