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

NCT00852332 | Terminated Phase 2

• 4 other identifiers: CDR0000635901JEANP-CURRYTAXINCA-RECF0908EUDRACT-2008-003930-19
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Response rate as assessed by RECIST criteria

  From the date of randomization until the end of the treatment, assessed up to 21 weeks

Secondary Outcomes (4)

• Overall clinical benefit rate as assessed by RECIST criteria

  From the date of randomization until the end of the treatment, assessed up to 21 weeks

• Time to progression as assessed by RECIST criteria

  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

  From the date of randomization until the date of death from any cause

• Safety as assessed by NCI CTCAE v3.0

  From the date of randomization until the end of the treatment, assessed up to 21 weeks

Study Arms (2)

Curcumine

EXPERIMENTAL

With curcumin capsules

Dietary Supplement: Curcumin; Drug: Taxotere

Drug taxotere only

ACTIVE COMPARATOR

Without curcumin

Drug: Taxotere

Interventions

Curcumin DIETARY_SUPPLEMENT

Curcumine

Taxotere DRUG

Curcumine; Drug taxotere only

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Curcumin; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Philippe Chollet, MD, PhD

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

FR (1)