Status:
COMPLETED
Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Breast Cancer
Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patien...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable with curative intent.
- Prior treatment with a standard regimen of anthracycline and taxane.
- Female patients at least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Adequate organ and bone marrow function
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (For the part I component, patients with non-measurable disease are accepted.)
- Resolution of all clinically significant toxic effects
- Completion of all prior therapy ≥ 3 weeks prior to registration. Patients on bisphosphonate therapy may continue such therapy.
- Patients must be either post-menopausal, surgically sterile, or using effective contraception.
- Willing and able to comply with study procedures and sign informed consent
Exclusion
- History of any second malignancy within the last 5 years (except adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri).
- Patients receiving more than one adjuvant regimen or more than one metastatic regimen
- Known brain or leptomeningeal disease.
- Concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, biological therapy, hormonal therapy, radiotherapy, chemoembolization therapy, cryotherapy, targeted non-cytotoxic therapies, or patients planning to receive these treatments during the study.
- Prior treatment with capecitabine, XRP9881, or any investigational chemotherapy.
- History of hypersensitivity to taxanes, Polysorbate-80, or to compounds with similar chemical structures. Patients with known intolerance to fluoropyrimidines or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Concurrent treatment with potent inhibitors of cytochrome P450 3A4, or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to registration.
- Peripheral neuropathy grade ≥ 2.
- Any of the following within the 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4).
- History of inflammatory bowel disease or chronic diarrhea.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
- Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation or that may cause undue risk for the patient's safety.
- Known human immunodeficiency virus (HIV) infection requiring treatment or acquired immunodeficiency-syndrome (AIDS)-related illness.
- Patients who are pregnant or breastfeeding.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00327743
Start Date
August 1 2006
End Date
March 1 2009
Last Update
May 18 2016
Active Locations (2)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Paris, France