Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327743
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : May 18, 2016
Information provided by (Responsible Party):

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 patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer Drug: larotaxel Drug: capecitabine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy
Study Start Date : August 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: larotaxel + Capecitabine Drug: larotaxel
IV infusion on Day 1 of a 21-day cycle
Other Name: XRP9881
Drug: capecitabine
oral, twice daily, Day 1-Day 14 of a 21-day cycle

Primary Outcome Measures :
  1. Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine [ Time Frame: study period ]

Secondary Outcome Measures :
  1. Response in patients with measurable disease [ Time Frame: study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00327743

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Study Director: ICD Sanofi

Responsible Party: Sanofi Identifier: NCT00327743     History of Changes
Other Study ID Numbers: TCD6511
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Cancer Alternative Therapies
Metastatic Breast Cancer

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