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Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma


OBJECTIVES:

- 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.

Inclusion 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

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/mm^3

- Platelet count ≥ 100,000/mm^3

- 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

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Principal Investigator

Tracey O'Connor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000363790

NCT ID:

NCT00083148

Start Date:

November 2002

Completion Date:

September 2006

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263