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

July 20, 2018 updated by: Centre Jean Perrin

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Curcumine
With curcumin capsules
Drug: Taxotere
Dietary supplement: Curcumin
ACTIVE_COMPARATOR: Drug taxotere only
Without curcumin
Drug: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From the date of randomization until the end of the treatment, assessed up to 21 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
From the date of randomization until the date of death from any 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
From the date of randomization until the end of the treatment, assessed up to 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Investigators

  • Principal Investigator: Philippe Chollet, MD, PhD, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (ESTIMATE)

February 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000635901
  • JEANP-CURRYTAX
  • INCA-RECF0908
  • EUDRACT-2008-003930-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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