Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4 Suppl 9
pubmed:dateCreated
1995-9-21
pubmed:abstractText
A phase I study was conducted to define the maximally tolerated dose and toxicity profile of the ifosfamide/carboplatin/etoposide/paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) (ICE-T) regimen in advanced lung cancer. This chemotherapy program uses paclitaxel given as a 24-hour continuous infusion in conjunction with full-dose ICE chemotherapy with growth factor support. The dosage of paclitaxel was escalated from 75 to 225 mg/m2. Thirty-four patients have been accrued to date onto this study. Because hematologic dose-limiting toxicity was defined in terms of neutropenia and/or thrombocytopenia exceeding 7 days' duration, no patient demonstrated what was defined by the protocol as dose-limiting toxicity. Nonetheless, substantial hematologic toxicity was observed. Overall, 26% had fever and neutropenia, 56% had grade 4 neutropenia, and 26% had grade 4 thrombocytopenia. In all cases, hematologic toxicity was short term and reversible. While grade 3 and 4 myelosuppression was frequently observed, it was not dose related (in terms of paclitaxel dosage). Nonhematologic toxicity also was not dose related and, with only a few exceptions, was not clinically significant. Among 27 patients evaluable for response, 41% achieved an objective response, including 15% with a complete response. All of five patients with small cell lung cancer responded (including two with a complete response). Among 22 patients with non-small cell lung cancer, 27% achieved an objective response (also including two with a complete response). The results of this study suggest that with growth factor support, it is possible to safely administer full-dose, single-agent paclitaxel in conjunction with full-dose ICE chemotherapy. We will soon be initiating a phase II study of the ICE-T regimen using paclitaxel at 225 mg/m2 as a 24-hour continuous infusion in advanced lung cancer. We will also conduct a phase I study of ICE-T, with paclitaxel administered as a 3-hour continuous infusion.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
0093-7754
pubmed:author
pubmed:issnType
Print
pubmed:volume
22
pubmed:owner
NLM
pubmed:authorsComplete
N
pubmed:pagination
70-4
pubmed:dateRevised
2006-4-24
pubmed:meshHeading
pubmed-meshheading:7544029-Adult, pubmed-meshheading:7544029-Aged, pubmed-meshheading:7544029-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:7544029-Bone Marrow, pubmed-meshheading:7544029-Carboplatin, pubmed-meshheading:7544029-Carcinoma, Non-Small-Cell Lung, pubmed-meshheading:7544029-Carcinoma, Small Cell, pubmed-meshheading:7544029-Cohort Studies, pubmed-meshheading:7544029-Drug Tolerance, pubmed-meshheading:7544029-Etoposide, pubmed-meshheading:7544029-Female, pubmed-meshheading:7544029-Granulocyte Colony-Stimulating Factor, pubmed-meshheading:7544029-Humans, pubmed-meshheading:7544029-Ifosfamide, pubmed-meshheading:7544029-Infusions, Intravenous, pubmed-meshheading:7544029-Lung Neoplasms, pubmed-meshheading:7544029-Male, pubmed-meshheading:7544029-Middle Aged, pubmed-meshheading:7544029-Neutropenia, pubmed-meshheading:7544029-Paclitaxel, pubmed-meshheading:7544029-Remission Induction, pubmed-meshheading:7544029-Thrombocytopenia
pubmed:year
1995
pubmed:articleTitle
A phase I study of ifosfamide/carboplatin/etoposide/paclitaxel in advanced lung cancer.
pubmed:affiliation
Division of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Clinical Trial, Phase I