Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer

NCT ID: NCT00615940

Last Updated: 2014-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-04-30

Brief Summary

This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with WX-671 once daily by mouth, Days 1-21 inclusive.

Group Type: EXPERIMENTAL

WX-671

Intervention Type: DRUG

capsules taken per os once daily until progression or toxicity

2

Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with placebo once daily by mouth, Days 1-21 inclusive.

Group Type: EXPERIMENTAL

placebo

Intervention Type: DRUG

capsule taken per os once daily until progression or toxicity

Interventions

WX-671

capsules taken per os once daily until progression or toxicity

Intervention Type: DRUG

placebo

capsule taken per os once daily until progression or toxicity

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Females aged ≥ 18 years
• Patients appropriate for palliative first-line, mono chemotherapy with capecitabine
• Histological or cytological confirmed, non-inflammatory metastatic breast cancer
• Availability of paraffin-embedded tumor tissue from the primary resection or biopsy of a metastatic lesion.
• HER2-negative breast cancer
• Complete staging within 2 weeks prior to randomization (4 weeks for bone scan).
• Radiologically confirmed disease
• ECOG performance status of ≤ 2
• Ability to understand and willingness to voluntarily sign and date a written informed consent form before screening
• Negative pregnancy test (urine or serum) within 3 days before first study drug for women of childbearing potential. Use of effective contraception during the study and for 3 months after stopping study drug treatment.
• Normal organ and marrow function as defined by laboratory parameters (obtained within the screening period) within the following limits:

• neutrophils >= 1.5 x 109/L;
• platelets >= 100 x 109/L;
• hemoglobin >= 9.0 g/dL (5.6 mmol/L).
• total bilirubin <= 1.5 x upper limit of normal (ULN);
• aspartate aminotransferase (AST)/ALT <= 2.5 x ULN (< 5.0 x ULN for patients with liver metastases);
• serum creatinine <= 2 x ULN, or calculated creatinine clearance >45 mL/min according to Cockroft and Gault formula).

Exclusion Criteria

• Endocrine therapy completed within 2 weeks before the start of treatment (i.e. previous hormone therapy is allowed provided that there is a washout period of 2 weeks).
• Prior chemotherapy or biologic therapy for metastatic disease.
• Major surgery within 4 weeks prior to the start of treatment.
• Other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of treatment.
• Treatment within 12 months with adjuvant 5-FU containing chemotherapy (regarded as indicating 5-FU resistance) and/or prior capecitabine therapy.
• Radiation therapy. Palliative radiation of stable, non-target lesions more than 2 weeks before the start of treatment is allowed, provided patients have recovered from the radiation side-effects.
• History of or radiological evidence of brain metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
• Active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months.
• History of other malignancy within the last 3 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
• Active cardiac disease e.g. unstable angina, congestive heart failure, myocardial infarction (MI) within the preceding 6 months.
• Any medical condition prohibiting standard imaging procedures
• Pregnant or breast-feeding.
• Any unrelated illness, e.g. active infection requiring parenteral antibiotics, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect patients' study participation.
• Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of either study drug.
• Known hepatitis B/C or HIV (human immunodeficiency virus) infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Heidelberg Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USA

Nadia Harbeck, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln

Locations

Montefiore Medical Center Weiler Division Department

New York, New York, United States

Universitys Hospital Case Medical Center

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

AZ Klina, Oncology Department

Brasschaat, , Belgium

Institut Jules Bordet Oncologie Médicale

Brussels, , Belgium

CHU de Liège, Domaine Universitaire de Sart-Tilman, Oncology Department

Liège, , Belgium

Irmandade de Misericórdia da Santa Casa de Porto Alegre

Porto Alegre, , Brazil

Instituto Nacional do Câncer - INCA

Rio de Janeiro, , Brazil

Instituto Brasileiro de Controle do Câncer - IBCC

São Paulo, , Brazil

Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter

Augsburg, , Germany

Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln

Cologne, , Germany

Universitätsklinikum Essen, Innere Klinik und Poliklinik (Tumorforschung)

Essen, , Germany

Uniklinik Frankfurt, Zentrum der Frauenheilkunde und Geburtshilfe

Frankfurt am Main, , Germany

Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg, Poliklinik Gynäkologie

Halle, , Germany

Bethesda KH

Mönchengladbach, , Germany

Department of Obstetrics and Gynecology, Technical University

Munich, , Germany

Davidof Center, Rabin Medical Center, Department of Oncology

Petah Tikva, , Israel

Kaplan Medical Center, Department of Oncolocy

Rehovot, , Israel

Sheba Medical Center, Department of Oncology

Tel Litwinsky, , Israel

Assaf Harofeh medical center, Department of Oncology

Ẕerifin, , Israel

Countries

United States; Belgium; Brazil; Germany; Israel

Other Identifiers

WX/60-006

Identifier Type: -

Identifier Source: org_study_id