Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

NCT00031876 | Completed Phase 1 DMC

• 2 other identifiers: SAKK 26/00EU-20135
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

capecitabine DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (2)

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Related 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):54-60. doi: 10.1159/000100449. Epub 2007 Mar 5.

  PMID: 17344671 RESULT

• 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 phase I dose-finding trial. Oncology. 2004;67(2):117-22. doi: 10.1159/000080997.

  PMID: 15539915 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Stefan Aebi, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2000
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

CH (2)