| 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 |
Related Documents
:
|
16328044 - A phase i trial of docetaxel and vinorelbine in patients with advanced non-small cell l... 11263504 - Second line chemotherapy with docetaxel in patients with recurrent malignant glioma: a ... 19390944 - Intermittent docetaxel therapy with estramustine for hormone-refractory prostate cancer... 12759524 - Weekly low-dose docetaxel in advanced hormone-resistant prostate cancer patients previo... 19639434 - Prognostic impact of treatment modalities on patients with single nodular recurrence of... 21168904 - Twelve-year experience with laparoscopic radical hysterectomy and pelvic lymphadenectom... |
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: 2007-11-14 |
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. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| 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; 114977-28-5/docetaxel; 33069-62-4/Paclitaxel; 50-02-2/Dexamethasone; 58-73-1/Diphenhydramine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Factors influencing the distribution of metastases and survival in metastatic breast carcinoma.
Next Document: Phase II study of cisplatin, 5-fluorouracil, and leucovorin in inoperable squamous cell carcinoma of...