Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
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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: Phase I/II trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: capecitabine Drug: paclitaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer |
| Enrollment: | 34 |
| Study Start Date: | May 2000 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of capecitabine when combined with paclitaxel in patients with metastatic adenocarcinoma of the breast.
- Determine the clinical efficacy of the dose immediately preceding the MTD identified in phase I, in terms of response rate, time to treatment failure, time to disease progression, and overall survival, in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine a well-tolerated drug combination for these patients.
OUTLINE: This is a dose-escalation, multicenter study of capecitabine.
Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on days 1, 8, and 15. 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 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the dose level immediately preceding the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and 15-46 patients will be accrued for phase II of this study.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
Patients in phase I:
- Evaluable disease
Patients in phase II:
Bidimensionally measurable disease
- Bone metastases are not considered measurable
- No known or clinically suspected CNS metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 to 64
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC greater than 3,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2 times ULN (3 times ULN if liver metastases present)
Renal:
Patients in phase I:
- Creatinine clearance at least 50 mL/min
Patients in phase I or II:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No grade 2 or greater atrioventricular block
Other:
- No cognitive impairment or severe psychiatric disorder
- No greater than grade 2 preexisting peripheral neuropathy
- No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- Able to tolerate steroid premedication
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- More than 6 months since prior adjuvant chemotherapy
- At least 1 year since prior continuous infusion of fluorouracil or capecitabine
- At least 1 year since prior taxane administered once every 3 weeks
- No prior taxane or capecitabine administered weekly
- No more than 1 prior chemotherapy regimen for metastatic or locally advanced breast cancer
- No other concurrent chemotherapy
Endocrine therapy:
- Prior hormonal treatment for metastatic breast cancer allowed
- No concurrent continuous glucocorticosteroids
- No concurrent systemic endocrine treatment for breast cancer
Radiotherapy:
- No concurrent radiotherapy to indicator lesion or more than 30% of bone marrow
Surgery:
- Not specified
Other:
- No other concurrent anticancer treatment
- No concurrent immunosuppressive drugs
- Concurrent bisphosphonates allowed if indicator lesion is non-bone
- Able to tolerate steroid premedication
Contacts and Locations| Switzerland | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| UniversitaetsSpital | |
| Zurich, Switzerland, CH-8091 | |
| Study Chair: | Stefan Aebi, MD | University Hospital Inselspital, Berne |
More Information
Publications:
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00031876 History of Changes |
| Other Study ID Numbers: | SAKK 26/00, EU-20135 |
| Study First Received: | March 8, 2002 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Swiss Group for Clinical Cancer Research:
|
stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Capecitabine Fluorouracil Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013