Back to resultsDocetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Curcumin
Taxotere
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring male breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIA breast cancer, HER2-negative breast cancer
Eligibility Criteria
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
Sites / Locations
- Centre Jean Perrin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Curcumine
Drug taxotere only
Arm Description
With curcumin capsules
Without curcumin
Outcomes
Primary Outcome Measures
Response rate as assessed by RECIST criteria
Secondary Outcome Measures
Overall clinical benefit rate as assessed by RECIST criteria
Time to progression as assessed by RECIST criteria
Overall survival as assessed by RECIST criteria
Evaluate overall survival (between inclusion and death whatever the cause)
Safety as assessed by NCI CTCAE v3.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00852332
Brief Title
Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
The trial was stopped for futility in view of the results of the anticipated analysis
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
male breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIA breast cancer, HER2-negative breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcumine
Arm Type
Experimental
Arm Description
With curcumin capsules
Arm Title
Drug taxotere only
Arm Type
Active Comparator
Arm Description
Without curcumin
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Type
Drug
Intervention Name(s)
Taxotere
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Overall survival as assessed by RECIST criteria
Description
Evaluate overall survival (between inclusion and death whatever the cause)
Time Frame
From the date of randomization until the date of death from any cause
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Chollet, MD, PhD
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
12. IPD Sharing Statement
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Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
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