AzTrials
AzTrials

Breast CancerPhase 1/2NCT00003902

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

A Phase 1/2 study testing capecitabine and vinorelbine tartrate in people with Breast Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
capecitabine and vinorelbine tartrate
How many people
110 participants
Where
1 siteSwitzerland
Study dates
Mar 1999to Sep 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
capecitabine, vinorelbine tartrate
Keywords
stage IV breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (2)

  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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1999
  3. Primary completionDec 2004
  4. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003902
Sponsor's protocol ID
SAKK 25/99
Other IDs
SWS-SAKK-25/99, EU-99007
Status last verified
May 2012
First submitted
1 Nov 1999
Last updated
15 May 2012
Results posted
No

Publications

  • 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.

    PubMed 18424887

  • 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.

    PubMed 15550580

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing capecitabine and vinorelbine tartrate in people with Breast Cancer, run by Swiss Cancer Institute at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum-tolerated dose (phase I). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003902, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in