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Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement
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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 tartrate | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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)
| Estimated Enrollment: | 110 |
| Study Start Date: | March 1999 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00003902
| Switzerland | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Study Chair: | Dagmar Hess, MD | Cantonal Hospital of St. Gallen |
More Information
Publications:
| 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 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 14, 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 |
ClinicalTrials.gov processed this record on July 21, 2017