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Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer

Phase 1/Phase 2
18 Years
64 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer


- Determine the maximum tolerated dose (MTD) of capecitabine when combined with
paclitaxel in patients with metastatic adenocarcinoma of the breast.

- Determine the clinical efficacy of the dose immediately preceding the MTD identified in
phase I, in terms of response rate, time to treatment failure, time to disease
progression, and overall survival, in these patients.

- Determine the toxicity of this regimen in these patients.

- Determine a well-tolerated drug combination for these patients.

OUTLINE: This is a dose-escalation, multicenter study of capecitabine.

Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on
days 1, 8, and 15. Treatment repeats every 21 days for a maximum of 6 courses in the absence
of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 or more of 6 patients
experience dose-limiting toxicity. Once the MTD is determined, additional patients are
treated at the dose level immediately preceding the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and 15-46 patients
will be accrued for phase II of this study.

Inclusion Criteria


- Histologically or cytologically confirmed metastatic adenocarcinoma of the breast

- Patients in phase I:

- Evaluable disease

- Patients in phase II:

- Bidimensionally measurable disease

- Bone metastases are not considered measurable

- No known or clinically suspected CNS metastases

- Hormone receptor status:

- Not specified



- 18 to 64


- Not specified

Menopausal status:

- Not specified

Performance status:

- WHO 0-2

Life expectancy:

- At least 12 weeks


- WBC greater than 3,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin at least 10 g/dL


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST/ALT no greater than 2 times ULN (3 times ULN if liver metastases present)


- Patients in phase I:

- Creatinine clearance at least 50 mL/min

- Patients in phase I or II:

- Creatinine no greater than 1.5 times ULN


- No grade 2 or greater atrioventricular block


- No cognitive impairment or severe psychiatric disorder

- No greater than grade 2 preexisting peripheral neuropathy

- No other prior or concurrent malignancy except adequately treated carcinoma in situ
of the cervix or basal cell or squamous cell skin cancer

- Able to tolerate steroid premedication


Biologic therapy:

- Not specified


- More than 6 months since prior adjuvant chemotherapy

- At least 1 year since prior continuous infusion of fluorouracil or capecitabine

- At least 1 year since prior taxane administered once every 3 weeks

- No prior taxane or capecitabine administered weekly

- No more than 1 prior chemotherapy regimen for metastatic or locally advanced breast

- No other concurrent chemotherapy

Endocrine therapy:

- Prior hormonal treatment for metastatic breast cancer allowed

- No concurrent continuous glucocorticosteroids

- No concurrent systemic endocrine treatment for breast cancer


- No concurrent radiotherapy to indicator lesion or more than 30% of bone marrow


- Not specified


- No other concurrent anticancer treatment

- No concurrent immunosuppressive drugs

- Concurrent bisphosphonates allowed if indicator lesion is non-bone

- Able to tolerate steroid premedication

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stefan Aebi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Inselspital, Berne


Switzerland: Swissmedic

Study ID:

SAKK 26/00



Start Date:

May 2000

Completion Date:

September 2004

Related Keywords:

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