Journal
CLINICAL GENITOURINARY CANCER
Volume 7, Issue 1, Pages 24-27Publisher
CIG MEDIA GROUP, LP
DOI: 10.3816/CGC.2009.n.004
Keywords
Hypertriglyceridemia; Kidney cancer; Mammalian target of rapamycin; Mucositis; Targeted therapy
Categories
Funding
- NCI NIH HHS [R25 CA020449, T32 CA009207, T32 CA009207-35] Funding Source: Medline
- NATIONAL CANCER INSTITUTE [T32CA009207] Funding Source: NIH RePORTER
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Purpose: Concurrent inhibition of multiple oncogenic signaling pathways might improve the efficacy of anticancer agents and abrogate resistance mechanisms. This phase I study evaluated temsirolimus in combination with sunitinib in patients with advanced RCC. Patients and Methods: Eligibility included advanced RCC and <= 2 previous systemic regimens. At the starting dose, temsirolimus 15 mg was administered by intravenous (I.V.) infusion once weekly, and sunitinib 25 mg was administered orally once daily for 4 weeks, followed by a 2-week rest period. Results: In the first cohort, dose-limiting toxicities (grade 3 treatment-related toxicities that lasted >= 7 days) were observed in 2 of 3 patients. One patient experienced grade 3 rash during week 3, which led to treatment discontinuation. A second patient had grade 3 thrombocytopenia (platelet count, 48,000/mu L), cellulitis, and gout during week 3 and was hospitalized; platelets recovered to 109,000/mu L 4 days after discontinuation of protocol therapy. A third patient experienced rash, asthenia, diarrhea, stomatitis, constipation, fever, and rectal hemorrhage, all of which were mild in severity. The study was terminated because of dose-limiting toxicity observed at low starting doses of both agents. Conclusion: Concomitant use of I.V temsirolimus 15 mg weekly and oral sunitinib 25 mg daily (4 weeks on, 2 weeks off) is not recommended.
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