Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

Sponsor

Swiss Group for Clinical Cancer Research (Other)

Overall Status

Completed

CT.gov ID

NCT00031876

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: capecitabine Drug: paclitaxel	Phase 1/Phase 2

Detailed Description

OBJECTIVES:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Sep 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 to 64

Sex:

Not specified

Menopausal status:

Not specified

Performance status:

WHO 0-2

Life expectancy:

At least 12 weeks

Hematopoietic:

WBC greater than 3,500/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic:

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)

Renal:

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

Cardiovascular:

No grade 2 or greater atrioventricular block

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

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 cancer
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

Radiotherapy:

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

Surgery:

Not specified

Other:

No other concurrent anticancer treatment
No concurrent immunosuppressive drugs
Concurrent bisphosphonates allowed if indicator lesion is non-bone
Able to tolerate steroid premedication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inselspital, Bern	Bern		Switzerland	CH-3010
2	UniversitaetsSpital	Zurich		Switzerland	CH-8091

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair: Stefan Aebi, MD, University Hospital Inselspital, Berne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Swiss Group for Clinical Cancer Research

ClinicalTrials.gov Identifier:

NCT00031876

Other Study ID Numbers:

SAKK 26/00
EU-20135

First Posted:

Jan 27, 2003

Last Update Posted:

May 15, 2012

Last Verified:

May 1, 2012

Keywords provided by Swiss Group for Clinical Cancer Research

stage IV breast cancer

recurrent breast cancer

Additional relevant MeSH terms:

Breast Neoplasms

Paclitaxel

Capecitabine

Study Results

No Results Posted as of May 15, 2012