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

Alternate Title

Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	65 and over	Other	SWS-SAKK-25/99 EU-99007, NCT00003902

Objectives

1. Determine the maximum tolerated dose of capecitabine and vinorelbine in elderly women (65 and older) with metastatic breast cancer.
2. Evaluate the efficacy and tolerability of this regimen in these patients.
3. Assess the time to treatment failure for this regimen as a first line chemotherapy in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically proven adenocarcinoma of the breast



• Phase I: Measurable or evaluable disease



• Phase II: Bidimensionally measurable disease



• No CNS metastases



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• More than 6 months since prior adjuvant chemotherapy
• No prior chemotherapy for metastatic or locally advanced disease
• No other concurrent chemotherapy

Endocrine therapy:

• Prior hormonal therapy for metastatic disease allowed
• No continuous concurrent steroids
• No concurrent systemic endocrine therapy for breast cancer
• No other concurrent endocrine therapy

Radiotherapy:

• No concurrent radiotherapy involving greater than 30% of bone marrow or mucosa
• Radiotherapy to nonindicator lesion allowed

Surgery:

• Not specified

Other:

• Bisphosphonates allowed if indicator lesion in nonbone site

Patient Characteristics:

Age:

• 65 and over

Sex:

• Female

Menopausal status:

• Postmenopausal

Performance status:

• ECOG/SAKK 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Normal peripheral blood counts

Hepatic:

• AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastases present)

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No other prior or concurrent malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
• No peripheral neuropathy grade 2 or higher
• No cognitive impairment or severe psychiatric disorder

Expected Enrollment

A total of 98-110 patients will be accrued for this study.

Outcomes

Maximum-tolerated dose (phase I)
Response rate at the end of study treatment (phase II)
Toxicity at the end of study treatment (phase II)

Time to treatment failure at end of study treatment (phase II)
Quality of life by Linear Analogue Self-Assessment indicators with 6 assessments until the end of the course 4 (phase II)

Outline

This is a dose-escalation study of capecitabine and vinorelbine. Patients are stratified according to bone involvement (yes [closed to accrual as of 12/7/04] vs no).

• Phase I: Patients receive oral capecitabine twice daily on days 1-14 and vinorelbine IV over 6-10 minutes on days 1 and 8. 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 and vinorelbine until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.




• Phase II: Patients receive capecitabine and vinorelbine administered as in phase I, at the dose preceding the MTD.

Quality of life is assessed during phase II on days 1, 8, and 15 of course 1 and on day 1 of courses 2-4.

Patients are followed every 3 months until disease progression or start of any subsequent antitumor treatment.

Hess D, Koberle D, Thurlimann B, et al.: Capecitabine and vinorelbine as first-line treatment in elderly patients (> or =65 years) with metastatic breast cancer. A phase II trial (SAKK 25/99). Oncology 73 (3-4): 228-37, 2007.[PUBMED Abstract]

Hess D, Thürlimann B, Pagani O, et al.: Capecitabine and vinorelbine in elderly patients (> or =65 years) with metastatic breast cancer: a phase I trial (SAKK 25/99). Ann Oncol 15 (12): 1760-5, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Dagmar Hess, MD, Protocol chair		Ph: 41-71-494-1111 Email: dagmar.hess@kssg.ch

Registry Information
Official Title		Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement
Trial Start Date		1999-03-10
Registered in ClinicalTrials.gov		NCT00003902
Date Submitted to PDQ		1999-05-12
Information Last Verified		2006-05-02

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