Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI RPCI-RP-0221 NCT00083148

Objectives

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• 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

Radiotherapy

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

Surgery

• More than 4 weeks since prior major surgery

Other

• No concurrent high-dose IV cyclosporine

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL

Hepatic

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

Renal

• Creatinine ≤ 1.5 times ULN

  OR

• Creatinine clearance ≥ 50 mL/min

Other

• 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

Expected Enrollment

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

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.

O'connor T, Rustum Y, Levine E, et al.: A phase I study of capecitabine and a modulatory dose of irinotecan in metastatic breast cancer. Cancer Chemother Pharmacol 61 (1): 125-31, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Tracey O'Connor, MD, Principal investigator		Ph: 716-845-1742; 800-685-6825

Registry Information
Official Title		Phase I Study of Irinotecan Followed by Capecitabine in Patients with Advanced Breast Carcinoma
Trial Start Date		2002-11-21
Registered in ClinicalTrials.gov		NCT00083148
Date Submitted to PDQ		2004-03-25
Information Last Verified		2005-05-28
NCI Grant/Contract Number		P30-CA16056

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