Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031876
• Other study ID #: SAKK 26/00
• Secondary ID: EU-20135
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 8, 2002
• Last updated: May 14, 2012
• Start date: May 2000
• Est. completion date: September 2004

Study information

• Verified date: May 2012
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical 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: Phase I/II trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine

• paclitaxel

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern	Bern
Switzerland	UniversitaetsSpital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Gick U, Rochlitz C, Mingrone W, Pestalozzi B, Rauch D, Ballabeni P, Lanz D, Hess V, Aebi S. Efficacy and tolerability of capecitabine with weekly paclitaxel for patients with metastatic breast cancer: a phase II report of the SAKK. Oncology. 2006;71(1-2): — View Citation

Uhlmann C, Ballabeni P, Rijken N, Brauchli P, Mingrone W, Rauch D, Pestalozzi BC, Rochlitz C, Aebi S; Swiss Group for Clinical Cancer Research; Swiss Institute for Applied Cancer Research. Capecitabine with weekly paclitaxel for advanced breast cancer: a — View Citation