Document Detail


Phase II study of docetaxel in advanced soft tissue sarcomas.
MedLine Citation:
PMID:  8931674     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Because of its unusual mechanism of action, docetaxel was selected for study in advanced soft tissue sarcomas of adults as part of a search for new active antisarcoma agents. Patients at least 18 years old with measurable histologically proven advanced nonosseous sarcomas were enrolled if they had ECOG performance status of < or = 2 and satisfactory leukocyte and platelet counts, and hepatic and renal function. Patients with Kaposi's sarcoma, mesothelioma, meningioma, embryonal rhabdomyosarcoma, and extraosseous Ewing's sarcoma were excluded, as were patients with brain or leptomeningeal metastases. Other specific contraindications to participation included other active cancer, previous or concurrent cancer chemotherapy or immunotherapy, and known allergy to the drug vehicle, polysorbate 80. Women of childbearing potential were required to have a negative pregnancy test. Following premedication with dexamethasone and diphenhydramine hydrochloride, docetaxel 100 mg/m2 as a concentrated solution containing 40 mg/ml in polysorbate 80 was infused over 1 h in 250 ml of either dextrose 5% in water or 0.9% saline. Treatment was repeated at 3-week intervals using standard definitions for objective responses. Up to two separate 25% toxicity directed dose reductions were permitted. Between May and December 1993, nine men and nine women registered (median age, 44 years). They received a total of 51 cycles of docetaxel (median, 2.5 cycles). Toxicity included moderate leukopenia (median first cycle nadir, 1.5 x 10(9)/L) but no significant thrombocytopenia. Alopecia, diarrhea, nausea, vomiting, and anorexia were common side effects. Fever, minor skin rashes, stomatitis, and edema were also observed. One drug-related death occurred in a neutropenic patient. One partial regression was observed (5.9%, 95% C.I. 0.15-28.7%) among the 17 eligible patients in a patient with metastatic uterine leiomyosarcoma.
Authors:
J H Edmonson; L P Ebbert; A G Nascimento; S H Jung; H McGaw; J B Gerstner
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  American journal of clinical oncology     Volume:  19     ISSN:  0277-3732     ISO Abbreviation:  Am. J. Clin. Oncol.     Publication Date:  1996 Dec 
Date Detail:
Created Date:  1996-12-26     Completed Date:  1996-12-26     Revised Date:  2013-05-28    
Medline Journal Info:
Nlm Unique ID:  8207754     Medline TA:  Am J Clin Oncol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  574-6     Citation Subset:  IM    
Affiliation:
Mayo Clinic, Rochester, Minnesota 55905, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Alopecia / chemically induced
Anorexia / chemically induced
Antiemetics / therapeutic use
Antineoplastic Agents, Phytogenic / administration & dosage,  adverse effects,  therapeutic use*
Cause of Death
Dexamethasone / therapeutic use
Diarrhea / chemically induced
Diphenhydramine / therapeutic use
Drug Administration Schedule
Female
Humans
Infusions, Intravenous
Leiomyosarcoma / drug therapy,  secondary
Leukopenia / chemically induced
Male
Middle Aged
Nausea / chemically induced
Paclitaxel / administration & dosage,  adverse effects,  analogs & derivatives*,  therapeutic use
Patient Selection
Premedication
Remission Induction
Sarcoma / drug therapy*
Taxoids*
Uterine Neoplasms / drug therapy
Vomiting / chemically induced
Grant Support
ID/Acronym/Agency:
CA-15083/CA/NCI NIH HHS; CA-25224/CA/NCI NIH HHS; CA-37404/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Antiemetics; 0/Antineoplastic Agents, Phytogenic; 0/Taxoids; 15H5577CQD/docetaxel; 33069-62-4/Paclitaxel; 50-02-2/Dexamethasone; 58-73-1/Diphenhydramine

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