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Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer

This study has been completed.
Information provided by:
Roswell Park Cancer Institute Identifier:
First received: May 14, 2004
Last updated: March 7, 2011
Last verified: March 2011

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capecitabine kill more tumor cells by making tumor cells more sensitive to the drug.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer.

Condition Intervention Phase
Breast Cancer Drug: capecitabine Drug: irinotecan hydrochloride Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Enrollment: 12
Study Start Date: November 2002
Study Completion Date: September 2006
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer.
  • Determine the degree of accumulation of cells in S-phase in tumor biopsies from patients treated with this regimen.
  • Determine the dose-limiting toxicity and other major or unusual toxic effects of this regimen in these patients.
  • Determine any antitumor activity of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen, including the active metabolite SN-38, in these patients.
  • Correlate pharmacokinetic parameters of this regimen with the biological changes observed in these patients.
  • Determine, preliminarily, the relationship of tumor response with modulation of S-phase in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive irinotecan IV over 1.5 hours on days 1, 8, 22, and 29 and oral capecitabine twice daily on days 1-14 and 23-36. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 8-37 patients will be accrued for this study within 18-24 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of breast cancer not eligible for potentially curative therapy or studies of higher priority

    • Advanced disease
    • Tumor accessible to biopsy AND not irradiated
  • Failed at least 1 prior chemotherapy regimen (not including adjuvant chemotherapy)
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL


  • AST ≤ 2 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN


  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active uncontrolled bacterial, viral, or fungal infection
  • No poor medical risk from non-malignant systemic disease


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • Prior irinotecan allowed
  • Prior carboplatin allowed
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy except for small port radiotherapy for local control


  • More than 4 weeks since prior major surgery


  • No concurrent high-dose IV cyclosporine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00083148

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Tracey O'Connor, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Tracey O'Connor, MD, Roswell Park Cancer Institute Identifier: NCT00083148     History of Changes
Other Study ID Numbers: CDR0000363790
Study First Received: May 14, 2004
Last Updated: March 7, 2011

Keywords provided by Roswell Park Cancer Institute:
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017