Search Clinical Trials
By Condition
By Location (USA)
By Location (Other)
By Sponsor
Resources
Privacy Policy
About Us
Disclaimer
Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement Clinical research trials and Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement. Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement clinical trial. Participants typically obtain the most effective healthcare available for their Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "C" Clinical Trials Conditions > Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement

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



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

For Condition: stage 4 breast cancer
Status: Recruiting
Sponsor(s): Swiss Institute for Applied Cancer Research ,
Synopsis: 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: Phase I/II trial to study the effectiveness of combining capecitabine and vinorelbine in treating older women who have metastatic breast cancer with or without bone involvement.
Details: 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 vs no). - 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 65 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
D.Hess,  Study Chair,  Kantonsspital - St. Gallen

Kantonsspital - St. Gallen *Recruiting*
St. Gallen,  ,  CH-9007
Switzerland
Recruiting D.  Hess 41-71-494-1111


Additional Information:
Study ID Numbers:
  CDR0000067077;  SWS-SAKK-25/99,EU-99007
Study Start Date: 
Record last reviewed: December 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003902

Other Stage 4 Breast Cancer Studies:
1. Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

2. Biological Therapy in Treating Patients With Advanced Cancer

3. Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer

4. Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer

5. Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer

Related Studies:

Other stage 4 breast cancer Clinical Trials
Other Clinical Trials
Other St. Gallen Clinical Trials

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

Modify your Search

  Other stage 4 breast cancer Clinical Trials
  Other Clinical Trials
  Other St. Gallen Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103