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

Sponsor:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003902

Purpose

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	Intervention	Phase
Breast Cancer	Drug: capecitabine Drug: vinorelbine ditartrate	Phase I Phase II

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate Capecitabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum-tolerated dose (phase I) [ Designated as safety issue: No ]
Response rate at the end of study treatment (phase II) [ Designated as safety issue: No ]
Toxicity at the end of study treatment (phase II) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to treatment failure at end of study treatment (phase II) [ Designated as safety issue: No ]
Quality of life by Linear Analogue Self-Assessment indicators with 6 assessments until the end of the course 4 (phase II) [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	March 1999

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003902

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

Kantonsspital - St. Gallen

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Hess D, Koberle D, Thurlimann B, Pagani O, Schonenberger A, Mattmann S, Rochlitz C, Rauch D, Schuller JC, Ballabeni P, Ribi K. Capecitabine and Vinorelbine as First-Line Treatment in Elderly Patients (>/=65 Years) with Metastatic Breast Cancer. A Phase II Trial (SAKK 25/99). Oncology. 2008 Apr 17;73(3-4):228-237 [Epub ahead of print]

Hess D, Thurlimann 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.

Study ID Numbers:	CDR0000067077, SWS-SAKK-25/99, EU-99007
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003902 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Vinblastine

Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vinorelbine
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009