Status:
COMPLETED
Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
Lead Sponsor:
Heidelberg Pharma AG
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00615940
Start Date
July 1 2008
End Date
April 1 2012
Last Update
February 28 2014
Active Locations (20)
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1
Montefiore Medical Center Weiler Division Department
New York, New York, United States, 10461
2
Universitys Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
4
AZ Klina, Oncology Department
Brasschaat, Belgium, 2930