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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00327743
First received: May 4, 2006
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Breast Cancer
Cancer
Drug: larotaxel (XRP9881)
Drug: capecitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response in patients with measurable disease [ Time Frame: study period ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: larotaxel (XRP9881)
    IV infusion
    Drug: capecitabine
    oral route
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.
  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: NCT00327743

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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00327743     History of Changes
Other Study ID Numbers: TCD6511, EudraCT:2006-006474-21
Study First Received: May 4, 2006
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Cancer Alternative Therapies
Metastatic Breast Cancer

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 September 22, 2014