NCT00003902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

5.8 years

First QC Date

November 1, 1999

Last Update Submit

May 14, 2012

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Outcome Measures

Primary Outcomes (3)

  • Maximum-tolerated dose (phase I)

  • Response rate at the end of study treatment (phase II)

  • Toxicity at the end of study treatment (phase II)

Secondary Outcomes (2)

  • 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)

Interventions

capecitabineDRUG
vinorelbine tartrateDRUG

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 18424887RESULT

  • 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. doi: 10.1093/annonc/mdh467.

    PMID: 15550580RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CapecitabineVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Dagmar Hess, MD

    Cantonal Hospital of St. Gallen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1999

Primary Completion

December 1, 2004

Study Completion

September 1, 2005

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CH(1)