Phase I study of chemotherapy with carboplatin, epirubicin, and escalating dose of VP-16 with G-CSF support in extensive small cell lung cancer

Am J Clin Oncol. 1996 Dec;19(6):589-91. doi: 10.1097/00000421-199612000-00012.

Abstract

In attempt to develop a new chemotherapeutic regimen including carboplatin (CBDCA), epirubicin (EPI), and VP-16 in extensive small cell lung cancer, with a higher dose intensity compared with previous experience of our group, we determined the maximum tolerated dose (MTD) of VP-16 when administered in association with CBDCA (300 mg/ m2, i.v., day 1) and EPI (75 mg/m2, i.v., day 1), recycling chemotherapy every 3 weeks, with the support of granulocyte-colony-stimulating factor (G-CSF). A total of 15 patients received three dose levels of VP-16 (mg/m2, i.v., daily on days 1-3): 100 (three patients), 120 (six), and 140 (six). G-CSF was administered subcutaneously at the dose of 5 micrograms/kg/day on days 6-15 of each chemotherapy course. The MTD was established at 140 mg/m2 and myelotoxicity, grade 4 neutropenia with death for sepsis in one case and grade 3 thrombocytopenia in three cases, was dose limiting. The recommended dose of VP-16 for a phase II study is 140 mg/m2.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Antibiotics, Antineoplastic / administration & dosage*
  • Antibiotics, Antineoplastic / adverse effects
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents, Phytogenic / administration & dosage*
  • Antineoplastic Agents, Phytogenic / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bone Marrow / drug effects
  • Carboplatin / administration & dosage*
  • Carboplatin / adverse effects
  • Carcinoma, Small Cell / drug therapy*
  • Cause of Death
  • Dose-Response Relationship, Drug
  • Drug Tolerance
  • Epirubicin / administration & dosage*
  • Epirubicin / adverse effects
  • Etoposide / administration & dosage*
  • Etoposide / adverse effects
  • Female
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Lung Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Neutropenia / prevention & control
  • Sepsis / etiology
  • Thrombocytopenia / chemically induced

Substances

  • Antibiotics, Antineoplastic
  • Antineoplastic Agents
  • Antineoplastic Agents, Phytogenic
  • Granulocyte Colony-Stimulating Factor
  • Epirubicin
  • Etoposide
  • Carboplatin