Phase I study of paclitaxel and etoposide for metastatic or recurrent malignancies. 1998

R C Lilenbaum, and D MacManus, and C Engstrom, and M Green
University of Maryland Cancer Center, Baltimore, USA.

The authors define the dose-limiting toxicities and the recommended phase II doses of paclitaxel combined with etoposide, without and with filgrastim support. Patients with advanced solid tumors were eligible if they had a performance status of 0 to 2 and normal renal, hepatic, and bone marrow function. Patients with cardiac arrhythmias or congestive heart failure requiring medical therapy were excluded. Prior radiation was allowed only if it involved less than 30% of the marrow-containing skeleton. The dose of etoposide was fixed at 100 mg/m2/d for 3 days beginning on day 1. Paclitaxel was administered over 3 hours on day 4. The dose of paclitaxel was escalated until the maximum tolerated dose (MTD), without and with filgrastim 5 microg/kg (or 300 microg total dose) subcutaneously beginning on day 5, was reached. Treatment cycles were repeated every 21 days. Of 39 patients entered, 37 were evaluable for toxicity and 30 for response. The principal toxicity was neutropenia. Without filgrastim, the MTD of paclitaxel was 150 mg/m2. With filgrastim, the dose of paclitaxel was escalated to 250 mg/m2 in combination with etoposide 100 mg/m2. One episode of pulmonary toxicity was observed. Five patients responded: two with previously treated non-small-cell lung cancer (NSCLC), two with refractory small-cell lung cancer (SCLC), and one with refractory germ-cell tumor (GCT). We conclude that paclitaxel and etoposide can be given in combination at clinically relevant doses with filgrastim support. In this phase I trial, a dose of paclitaxel of 200 mg/m2 on day 4 and etoposide at 100 mg/m2/d on days 1-3, with filgrastim 5 microg/kg beginning on day 5, was found to be well tolerated, and can be recommended for future studies. Without filgrastim, a paclitaxel dose of 150 mg/m2 with the same dose of etoposide can also be recommended.

UI MeSH Term Description Entries
D008175 Lung Neoplasms Tumors or cancer of the LUNG. Cancer of Lung,Lung Cancer,Pulmonary Cancer,Pulmonary Neoplasms,Cancer of the Lung,Neoplasms, Lung,Neoplasms, Pulmonary,Cancer, Lung,Cancer, Pulmonary,Cancers, Lung,Cancers, Pulmonary,Lung Cancers,Lung Neoplasm,Neoplasm, Lung,Neoplasm, Pulmonary,Pulmonary Cancers,Pulmonary Neoplasm
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011994 Recombinant Proteins Proteins prepared by recombinant DNA technology. Biosynthetic Protein,Biosynthetic Proteins,DNA Recombinant Proteins,Recombinant Protein,Proteins, Biosynthetic,Proteins, Recombinant DNA,DNA Proteins, Recombinant,Protein, Biosynthetic,Protein, Recombinant,Proteins, DNA Recombinant,Proteins, Recombinant,Recombinant DNA Proteins,Recombinant Proteins, DNA
D002289 Carcinoma, Non-Small-Cell Lung A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy. Carcinoma, Non-Small Cell Lung,Non-Small Cell Lung Cancer,Non-Small Cell Lung Carcinoma,Non-Small-Cell Lung Carcinoma,Nonsmall Cell Lung Cancer,Carcinoma, Non Small Cell Lung,Carcinomas, Non-Small-Cell Lung,Lung Carcinoma, Non-Small-Cell,Lung Carcinomas, Non-Small-Cell,Non Small Cell Lung Carcinoma,Non-Small-Cell Lung Carcinomas
D004334 Drug Administration Schedule Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience. Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D005047 Etoposide A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle. Demethyl Epipodophyllotoxin Ethylidine Glucoside,Celltop,Eposide,Eposin,Eto-GRY,Etomedac,Etopos,Etoposide Pierre Fabre,Etoposide Teva,Etoposide, (5S)-Isomer,Etoposide, (5a alpha)-Isomer,Etoposide, (5a alpha,9 alpha)-Isomer,Etoposide, alpha-D-Glucopyranosyl Isomer,Etoposido Ferrer Farma,Exitop,Lastet,NSC-141540,Onkoposid,Riboposid,Toposar,VP 16-213,VP-16,Vepesid,Vépéside-Sandoz,Eto GRY,Etoposide, alpha D Glucopyranosyl Isomer,NSC 141540,NSC141540,Teva, Etoposide,VP 16,VP 16 213,VP 16213,VP16,Vépéside Sandoz,alpha-D-Glucopyranosyl Isomer Etoposide
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069585 Filgrastim A recombinant granulocyte colony-stimulating factor (G-CSF) that is used in the treatment and prevention of NEUTROPENIA, preparation and collection of blood progenitor cells, and for use in PERIPHERAL BLOOD STEM CELL TRANSPLANTATION. Filgrastim-sndz,G-CSF Recombinant, Human Methionyl,Granix,Neupogen,R-metHuG-CSF,Recombinant-Methionyl Human Granulocyte Colony-Stimulating Factor,Tbo-Filgrastim,Topneuter,Zarxio,G CSF Recombinant, Human Methionyl,R metHuG CSF,Recombinant Methionyl Human Granulocyte Colony Stimulating Factor,Tbo Filgrastim

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