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

• Status: Terminated
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin
• Treatments: Curcumin; Docetaxel

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