Phase I trial of carboplatin and paclitaxel with escalating doses of oral topotecan in patients with solid tumors

Nasser Hanna, Chris Sweeney, Karen Fife, Sheila Dropcho, David E. Seitz

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Carboplatin, paclitaxel, and topotecan have activity against a variety of cancers. This phase I study was designed to determine the maximum tolerated dose of oral topotecan when given in combination with carboplatin and paclitaxel. Eligibility criteria were as follows: Karnofsky Performance score greater than or equal to 80; and adequate hepatic, renal, and bone marrow function. Patients received paclitaxel 175 mg/m2 intravenously followed by carboplatin AUC5 iv on day 1 every 3 weeks for up to 6 cycles. Cohorts of 3 to 5 were treated with escalating doses of oral topotecan on days 1 to 5, initially at 0.75 mg/m2 then 1 mg/m2 and 1.25 mg/m2 in subsequent cohorts. Thirteen patients were treated. Three of three patients in cohort 1 had grade IV neutropenia, with one neutropenic fever and one patient requiring a platelet transfusion. In cohort 2, three of five patients had grade III/IV neutropenia including two with neutropenic fever. Four patients required blood transfusions and one required platelet transfusions. In cohort 3, three of five had grade III/IV neutropenia, one of five had grade IV thrombocytopenia, and one patient required blood transfusions. In conclusion, this three-drug regimen resulted in significant cumulative myelosuppression in the doses and schedule tested in this phase I trial. Subsequent combinations of these drugs should focus on alternate doses or schedules.

Original languageEnglish
Pages (from-to)200-202
Number of pages3
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume26
Issue number2
DOIs
StatePublished - Apr 2003
Externally publishedYes

Fingerprint

Topotecan
Carboplatin
Paclitaxel
Neutropenia
Neoplasms
Platelet Transfusion
Blood Transfusion
Appointments and Schedules
Fever
Maximum Tolerated Dose
Drug Combinations
Thrombocytopenia
Bone Marrow
Kidney
Liver
Pharmaceutical Preparations

Keywords

  • Carboplatin
  • Oral topotecan
  • Paclitaxel
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase I trial of carboplatin and paclitaxel with escalating doses of oral topotecan in patients with solid tumors. / Hanna, Nasser; Sweeney, Chris; Fife, Karen; Dropcho, Sheila; Seitz, David E.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 26, No. 2, 04.2003, p. 200-202.

Research output: Contribution to journalArticle

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