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

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Wilex
ClinicalTrials.gov Identifier:
NCT00615940
First received: February 1, 2008
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: WX-671
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Wilex:

Primary Outcome Measures:
  • Efficacy in terms of progression-free survival (PFS) [ Time Frame: disease staging with CT/MRI/bone scans at regular intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints are objective response rate (ORR), overall survival, safety and pharmacokinetics. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 132
Study Start Date: July 2008
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: WX-671
capsules taken per os once daily until progression or toxicity
Experimental: 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.
Drug: placebo
capsule taken per os once daily until progression or toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615940

Locations
United States, New York
Montefiore Medical Center Weiler Division Department
New York, New York, United States, 10461
United States, Ohio
Universitys Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Belgium
AZ Klina, Oncology Department
Brasschaat, Belgium, 2930
Institut Jules Bordet Oncologie Médicale
Bruxelles, Belgium, 1000
CHU de Liège, Domaine Universitaire de Sart-Tilman, Oncology Department
Liège, Belgium, 4000
Brazil
Irmandade de Misericórdia da Santa Casa de Porto Alegre
Porto Alegre, Brazil, 9005
Instituto Nacional do Câncer - INCA
Rio de Janeiro, Brazil, 20560
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, Brazil, 03102
Germany
Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter
Augsburg, Germany, 86150
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln
Cologne, Germany
Universitätsklinikum Essen, Innere Klinik und Poliklinik (Tumorforschung)
Essen, Germany, 45147
Uniklinik Frankfurt, Zentrum der Frauenheilkunde und Geburtshilfe
Frankfurt/Main, Germany, 60590
Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg, Poliklinik Gynäkologie
Halle/Saale, Germany, 06120
Department of Obstetrics and Gynecology, Technical University
Munich, Germany, 81675
Bethesda KH
Mönchengladbach, Germany, 41061
Israel
Davidof Center, Rabin Medical Center, Department of Oncology
Petah Tikva, Israel, 49100
Kaplan Medical Center, Department of Oncolocy
Rehovot, Israel, 76100
Sheba Medical Center, Department of Oncology
Tel Hashomer, Israel, 52621
Assaf Harofeh medical center, Department of Oncology
Zerifin, Israel, 70300
Sponsors and Collaborators
Wilex
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Lori Goldstein, MD Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USA
Principal Investigator: Nadia Harbeck, MD Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln
  More Information

No publications provided

Responsible Party: Wilex
ClinicalTrials.gov Identifier: NCT00615940     History of Changes
Other Study ID Numbers: WX/60-006
Study First Received: February 1, 2008
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Brazil: National Health Surveillance Agency
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Ukraine: State Pharmacological Center - Ministry of Health
Israel: Ministry of Health

Keywords provided by Wilex:
HER2negative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014