Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC

NCT00201435 | Completed Phase 2

• 3 other identifiers: NBCG10REK 378-04-03133NMA 03-07568
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

We want to compare Taxol given weekly with Taxotere given every 3 week both in comination with Xeloda. We are going to compare time to treatment failure and quality of life.

Conditions

Breast Neoplasm

Keywords

Breast; Cancer; Paclitaxel; Docetaxel; Qulaity of life

Outcome Measures

Primary Outcomes (2)

• Time to treatment failure

• Quality of life

Secondary Outcomes (2)

• Response rates

• Overall survival

Interventions

Paclitaxel weekly in combination with capecitabine DRUG

Docetaxel every 3 week in combination with capecitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed patient consent Measurable and/or evaluable disease Measurable disease is defined as least one lesion that can be accurately measured in at least one dimension as ≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section 8.
• Evaluable metastases. Lytic bone metastases as only site of recurrence are allowed and can be evaluated for response according to the WHO-criteria for reporting on response in bone metastases.
• Age 18 years or older ECOG Performance Status 0-2 Life expectancy of at least three months Adequate cardiac functions
• Adequate hematological, renal and hepatic functions, defined as:
• White blood cell count \> 3.9 x 109/L Trombocytes \> 100 x 109/L Serum creatinine \< 1.25 x ULN\* Bilirubin \< 1.5 ULN If alkaline phosphatases (ALP) is normal ALAT \< 3.5 ULN ASAT \< 3.5 ULN If alkaline phosphatases (ALP) is \> 2.5 ULN ALAT \< 1.5 ULN ASAT \< 1.5 ULN

You may not qualify if:

• Neoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix, diagnosed during the past five years
• Pregnancy or lactation
• Known brain metastases
• Preexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria (severe paresthesia and/or mild weakness, or worse)
• Severe hepatic or renal impairment (for capecitabine: calculated creatinine clearance below 30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the proposed regimens
• History of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on previous treatment with fluorouracil)
• Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide, cyclosporine or vitamin K
• Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.

Sponsors & Collaborators

• Norwegian Breast Cancer Group: lead

Study Sites (1)

Ullevål university hospital

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; 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

Study Officials

• Erik Wist, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

NO (1)