Abstract | PURPOSE: EXPERIMENTAL DESIGN: RESULTS: A total of 45 patients were enrolled (18 patients in the Phase I dose escalation arm and 27 in the Phase IIA arm). The starting dose of squalamine was 100 mg/m(2)/day and escalated to 400 mg/m(2)/day; two of three patients at 400 mg/m(2)/day had dose-limiting toxicity that included grade 3/4 arthralgia, myalgia, and neutropenia. On the basis of safety and toxicity, 300 mg/m(2)/day was selected as the Phase II dose of squalamine in this combination regimen. An additional 27 patients (a total of 33) were enrolled according to the protocol treatment schema at 300 mg/m(2)/day. There was no pharmacokinetic evidence of drug interactions for the combination of squalamine, carboplatin, and paclitaxel. Forty-three patients were evaluable for response. Partial tumor responses were observed in 12 (28%) of these patients; an additional 8 evaluable patients (19%) were reported to have stable disease. For all of the patients treated, the median survival was 10.0 months; and 1-year survival was 40%. CONCLUSIONS:
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Authors | Roy S Herbst, Lisa A Hammond, David P Carbone, Hai T Tran, Kenneth J Holroyd, Avinash Desai, Jon I Williams, B Nebiyou Bekele, Howard Hait, Victoria Allgood, Stephen Solomon, Joan H Schiller |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 9
Issue 11
Pg. 4108-15
(Sep 15 2003)
ISSN: 1078-0432 [Print] United States |
PMID | 14519633
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Angiogenesis Inhibitors
- Cholestanols
- Lactates
- squalamine lactate
- Carboplatin
- squalamine
- Paclitaxel
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Angiogenesis Inhibitors
(administration & dosage, therapeutic use, toxicity)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carboplatin
(administration & dosage)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology)
- Cholestanols
(administration & dosage, therapeutic use, toxicity)
- Disease-Free Survival
- Female
- Humans
- Infusions, Intravenous
- Lactates
(administration & dosage, therapeutic use, toxicity)
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Middle Aged
- Neoplasm Staging
(mortality)
- Paclitaxel
(administration & dosage)
- Patient Selection
- Pleural Effusion
- Survival Analysis
- Time Factors
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