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Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00852332
Recruitment Status : Terminated (The trial was stopped for futility in view of the results of the anticipated analysis)
First Posted : February 27, 2009
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin

Tracking Information
First Submitted Date  ICMJE February 26, 2009
First Posted Date  ICMJE February 27, 2009
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Response rate as assessed by RECIST criteria [ Time Frame: From the date of randomization until the end of the treatment, assessed up to 21 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2009)
Response rate as assessed by RECIST criteria
Change History Complete list of historical versions of study NCT00852332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • Overall clinical benefit rate as assessed by RECIST criteria [ Time Frame: From the date of randomization until the end of the treatment, assessed up to 21 weeks ]
  • Time to progression as assessed by RECIST criteria [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 21 weeks ]
  • Overall survival as assessed by RECIST criteria [ Time Frame: From the date of randomization until the date of death from any cause ]
    Evaluate overall survival (between inclusion and death whatever the cause)
  • Safety as assessed by NCI CTCAE v3.0 [ Time Frame: From the date of randomization until the end of the treatment, assessed up to 21 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2009)
  • Overall clinical benefit rate as assessed by RECIST criteria
  • Time to progression as assessed by RECIST criteria
  • Overall survival as assessed by RECIST criteria
  • Safety as assessed by NCI CTCAE v3.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
Official Title  ICMJE An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of breast cancer. It is not yet known whether giving docetaxel together with a phytochemical is more effective than giving docetaxel alone in treating patients with breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a phytochemical works compared with giving docetaxel alone as first- or second-line therapy in treating patients with breast cancer.

Detailed Description

OBJECTIVES:

Primary

  • To compare the response rate in HER2-negative patients with locally advanced or metastatic breast cancer or locoregional breast cancer recurrence treated with docetaxel and a dietary phytochemical vs docetaxel alone.

Secondary

  • To compare the overall clinical benefit rate (i.e., objective response plus stable disease) in patients treated with these regimens.
  • To compare time to progression in patients treated with these regimens.
  • To compare overall survival of patients treated with these regimens.
  • To assess biomarkers of response in blood samples from patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to recruitment center and line of chemotherapy (first vs second line of docetaxel). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive docetaxel as in arm I. Patients also receive an oral dietary phytochemical twice on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Dietary Supplement: Curcumin
  • Drug: Taxotere
Study Arms  ICMJE
  • Experimental: Curcumine
    With curcumin capsules
    Interventions:
    • Dietary Supplement: Curcumin
    • Drug: Taxotere
  • Active Comparator: Drug taxotere only
    Without curcumin
    Intervention: Drug: Taxotere
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 20, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2009)
100
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast, meeting 1 of the following criteria:

    • Locally advanced disease
    • Documented metastatic disease without overexpression of Her2/neu

      • Must have received prior anthracycline-containing regimen as neoadjuvant, adjuvant, or first-line chemotherapy for metastatic breast cancer
    • Loco-regional recurrence not amenable to treatment by surgery or radiotherapy
  • At least one measurable lesion according to RECIST criteria

    • No bone lesion only disease
  • Must be a candidate for taxane-based chemotherapy
  • HER2-negative disease
  • No symptomatic brain metastases
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine < 140 µmol/L OR creatinine clearance > 60 mL/min
  • Total bilirubin ≤ upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of significant neurologic (i.e., peripheral neuropathy ≥ grade 2) or psychiatric disorders, including psychotic disorders, dementia, or seizures that would prohibit the understanding, observance, and giving of informed consent
  • No other prior or concomitant malignancies except adequately treated carcinoma in situ of the cervix uteri, basal cell or squamous cell carcinoma of the skin, or other cancer curatively treated with surgery and/or radiotherapy
  • No concurrent severe and/or uncontrolled co-morbid medical condition
  • No medically unstable patients
  • No uncontrolled infection
  • No autoimmune disease and/or chronic active inflammation
  • No psychological, familial, social, or geographical reasons that would make clinical follow-up impossible
  • No malabsorption syndrome or disease significantly affecting gastrointestinal function
  • No dysphagia ≥ grade 2
  • No history of hypersensitivity to taxanes or known excipients, including polysorbate 80

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior major resection of the stomach or proximal small bowel
  • Prior hormonal therapy as adjuvant treatment and/or treatment of metastatic disease allowed provided that the patient has progressive disease at study entry

    • Hormonal treatment must be discontinued prior to study entry
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • More than 30 days since prior investigational drug
  • More than 3 weeks since prior NSAIDs or COX_2 inhibitors
  • No other concurrent anticancer therapy
  • No other concurrent dietary phytonutrients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00852332
Other Study ID Numbers  ICMJE CDR0000635901
JEANP-CURRYTAX
INCA-RECF0908
EUDRACT-2008-003930-19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Jean Perrin
Study Sponsor  ICMJE Centre Jean Perrin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Chollet, MD, PhD Centre Jean Perrin
PRS Account Centre Jean Perrin
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP