A phase I study of capecitabine combined with CPT-11 in metastatic breast cancer pretreated with anthracyclines and taxanes.

Abstract

OBJECTIVE:

A dose escalation study of biweekly irinotecan (CPT-11) combined with capecitabine was performed to determine the maximum tolerated dose (MTD) and recommended dose (RD) for metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes.

METHODS:

Escalating doses of CPT-11 (80-120 mg/m(2)) were administered on days 1 and 15. Capecitabine was administered at a fixed dose of 1,657 mg/m(2)/day for 21 consecutive days, followed by 7 days of rest. We treated 3-6 patients at a particular dose level until the MTD was determined.

RESULTS:

Twenty patients were treated. The MTD was determined to be 100 mg/m(2), as 3 of 6 patients developed dose-limiting toxicities, grade 3 leukopenia, neutropenia, photophobia, fatigue and diarrhea. The RD for the phase II study was thus determined to be 90 mg/m(2). The response rate was 41.7%.

CONCLUSIONS:

Combination therapy with CPT-11 and capecitabine was well tolerated with a promising response rate for MBC that had been treated previously with anthracyclines and taxanes. A multi-center phase II study is warranted to evaluate the efficacy and safety of this combination therapy with pharmacokinetic assessment.

• Authors: Masahiro Kashiwaba, Toru Inaba, Hideaki Komatsu, Kazushige Ishida, Ryoko Kawagishi, Yusuke Matsui, Noriyuki Uesugi, Tamotsu Sugai, Go Wakabayashi
• Journal: Oncology (Oncology) Vol. 86 Issue 4 Pg. 206-11 ( 2014) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 24820348 (Publication Type: Clinical Trial, Phase I, Journal Article)
• Copyright: © 2014 S. Karger AG, Basel.

Chemical References

• Anthracyclines
• Antimetabolites, Antineoplastic
• Antineoplastic Agents, Phytogenic
• Taxoids
• Deoxycytidine
• Capecitabine
• Irinotecan
• Fluorouracil
• Camptothecin

Topics

• Adult
• Anthracyclines (administration & dosage)
• Antimetabolites, Antineoplastic (administration & dosage)
• Antineoplastic Agents, Phytogenic (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy)
• Camptothecin (administration & dosage, analogs & derivatives)
• Capecitabine
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Female
• Fluorouracil (administration & dosage, analogs & derivatives)
• Humans
• Irinotecan
• Middle Aged
• Taxoids (administration & dosage)