Dose-finding study of hepatic arterial infusion of irinotecan-based treatment in patients with advanced cancers metastatic to the liver.
Abstract | BACKGROUND: PATIENTS AND METHODS: RESULTS: From October 2009 through December 2013, 98 patients with various tumor types were enrolled (median age, 62 years, range, 34-85; and median number of prior therapies, 4, range, 1-11). In cohorts A and C, dose escalation continued until the highest dose level-considered the MTD-was reached. In cohort B, dose escalation continued until dose level 3, and dose level 2 was considered the MTD. Rates of grade 3/4 adverse events were as follows: diarrhea, 8 %; fatigue, 4 %; neutropenia, 4 %; thrombocytopenia, 2 %; and skin rash, 2 %. Seventy-seven patients were evaluable for response. Partial response was noted in 5 (6.5 %) patients (neuroendocrine cancer, n = 2; CRC, n = 2; NSCLC, n = 1); and stable disease ≥ 6 months in 17 (22.1 %) patients (CRC, n = 13; breast, n = 1; neuroendocrine, n = 1; NSCLC, n = 1; pancreatic, n = 1). CONCLUSIONS:
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Authors | Rabih Said, Razelle Kurzrock, Aung Naing, David S Hong, Siqing Fu, Sarina A Piha-Paul, Jennifer J Wheler, Filip Janku, Bryan K Kee, Savita Bidyasar, Joann Lim, Michael Wallace, Apostolia M Tsimberidou |
Journal | Investigational new drugs
(Invest New Drugs)
Vol. 33
Issue 4
Pg. 911-20
(Aug 2015)
ISSN: 1573-0646 [Electronic] United States |
PMID | 25990659
(Publication Type: Clinical Trial, Phase I, Journal Article)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- Organoplatinum Compounds
- Oxaliplatin
- Bevacizumab
- Irinotecan
- Cetuximab
- Camptothecin
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Phytogenic
(administration & dosage, adverse effects, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects, therapeutic use)
- Bevacizumab
(administration & dosage, adverse effects, therapeutic use)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Cetuximab
(administration & dosage, adverse effects, therapeutic use)
- Female
- Hepatic Artery
- Humans
- Infusions, Intra-Arterial
- Infusions, Intravenous
- Irinotecan
- Liver Neoplasms
(drug therapy, secondary)
- Male
- Maximum Tolerated Dose
- Middle Aged
- Organoplatinum Compounds
(administration & dosage, adverse effects, therapeutic use)
- Oxaliplatin
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