Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer

NCT00079170 | Completed

• 2 other identifiers: CDR0000355083NCI-04-C-0084
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether garlic supplements affect the ability of docetaxel to kill tumor cells. PURPOSE: This clinical trial is studying how well giving docetaxel together with garlic works in treating patients with locally advanced or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

male breast cancer; recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Interventions

garlic DIETARY_SUPPLEMENT

docetaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Incurable, locally advanced or metastatic disease for which therapy with docetaxel is a reasonable option * No documentation of progressive disease while on docetaxel within the past 2 months * Brain and/or leptomeningeal metastases are allowed only if all of the following criteria are met: * Asymptomatic on neurological examination, including after definitive radiotherapy * No corticosteroid therapy to control symptoms * Stable lesions * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal Status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Neutrophil count ≥ 1,200/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * ALT and AST ≤ 2 times ULN (3 times ULN with liver metastases) Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmias Gastrointestinal * No known gastric emptying disorders * No persistent diarrhea Other * No uncontrolled diabetes mellitus * No active infection * No prior grade 3 or 4 allergic reaction attributed to compounds of similar biological composition to garlic, docetaxel, or Tween 80 * No other concurrent uncontrolled medical condition that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * Must be able to ingest oral medication * Lactic dehydrogenase ≤ 2 times ULN PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 weeks since prior immunotherapy * No concurrent immunotherapy * Trastuzumab (Herceptin®) allowed after the first course of therapy at the discretion of the primary physician * No concurrent pegfilgrastim Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * At least 2 weeks since prior hormonal therapy * No concurrent hormonal therapy * No concurrent megestrol during the first course of study treatment Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 30 days (or 5 half-lives) since prior investigational therapy * No concurrent aprepitant (Emend®) * No concurrent or oral tetrahydrocannabinol (Marinol®) during the first course of study treatment * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or anticancer medications * No concurrent antiepileptic therapy * No concurrent immunosuppressants * No other concurrent herbal therapies during the first month of study participation * No concurrent grapefruit juice during the first month of study participation * No concurrent administration of the following: * Alprazolam * Cyclosporine * Diltiazem * Dofetilide * Erythromycin * Fluvoxamine * Itraconazole * Ketoconazole * Quinine * Hypericum perforatum (St. John's wort) * Tacrolimus * Theophylline * Warfarin * Zolpidem

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Michael C. Cox, PharmD

  NCI - Medical Oncology Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: January 1, 2004
• Study Completion: October 1, 2007
• Last Updated: June 20, 2013

Record last verified: 2006-10

Locations

US (1)