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

Study Description

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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: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: capecitabine; Drug: vinorelbine tartrate	Phase 1; Phase 2

Detailed Description:

OBJECTIVES:

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

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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	110 participants
Primary Purpose:	Treatment
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
Study Start Date :	March 1999
Actual Primary Completion Date :	December 2004
Actual Study Completion Date :	September 2005

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

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

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

Contacts and Locations

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Locations

Switzerland
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:	Dagmar Hess, MD	Cantonal Hospital of St. Gallen

More Information

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Publications of Results:

Hess D, Koberle D, Thurlimann B, Pagani O, Schonenberger A, Mattmann S, Rochlitz C, Rauch D, Schuller JC, Ballabeni P, Ribi K; Swiss Group for Clinical Cancer Research. 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. 2007;73(3-4):228-37. doi: 10.1159/000127414. Epub 2008 Apr 17.

Hess D, Thürlimann B, Pagani O, Aebi S, Rauch D, Ballabeni P, Rufener B, Castiglione-Gertsch M, Goldhirsch A; Swiss Group of Clinical Cancer Research (SAKK). Capecitabine and vinorelbine in elderly patients (> or =65 years) with metastatic breast cancer: a phase I trial (SAKK 25/99). Ann Oncol. 2004 Dec;15(12):1760-5.

Responsible Party:	Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:	NCT00003902 History of Changes
Other Study ID Numbers:	SAKK 25/99; SWS-SAKK-25/99; EU-99007
First Posted:	January 27, 2003
Last Update Posted:	May 15, 2012
Last Verified:	May 2012

Keywords provided by Swiss Group for Clinical Cancer Research:

stage IV breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Capecitabine; Vinorelbine; Vinblastine	Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators