Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer

NCT00074139 | Withdrawn Phase 1 DMC

• 4 other identifiers: CWRU040314CDR0000343609CWRU-AVEN-1103AVENTIS-XRP6976D/1001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them at different times, may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.

Conditions

Breast Cancer

Keywords

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

Interventions

cyclophosphamide DRUG

docetaxel DRUG

doxorubicin hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced breast cancer * Adjuvant setting for high-risk disease allowed * No symptomatic evidence or history of brain metastases * No leptomeningeal metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 to 69 Sex * Female Menopausal status * Not specified Performance status * WHO 0-2 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Neutrophil count at least 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic * Bilirubin less than upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN) * Alkaline phosphatase no greater than 5 times ULN Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * LVEF or shortening fraction greater than lower limit of normal by MUGA or echocardiography * Cardiac function normal * No congestive heart failure * No unstable angina pectoris * No myocardial infarction within the past year * No uncontrolled hypertension * No high-risk uncontrolled arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No active uncontrolled infection * No active peptic ulcer * No unstable diabetes mellitus * No other serious illness or medical condition * No contraindication to corticosteroids * No pre-existing grade 2 or greater motor or sensory neurotoxicity * No psychological, social, familial, or geographical reason that would preclude study follow-up * No history of significant neurologic or psychiatric disorder (e.g., psychotic disorder, dementia, or seizures) that would preclude understanding and giving informed consent * No other neoplasm within the past 10 years except curatively treated nonmelanoma skin cancer, carcinoma in situ of the cervix, ipsilateral ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 6 months since prior anthracycline or taxoid (e.g., paclitaxel or docetaxel) therapy * No prior cumulative anthracycline dose greater than 240 mg/m\^2 Endocrine therapy * Concurrent corticosteroid treatment allowed provided treatment was initiated more than 6 months before study entry and at a dose of less than 20 mg of methylprednisolone or equivalent * No concurrent ovarian hormonal replacement therapy Radiotherapy * Not specified Surgery * More than 2 weeks since prior major surgery Other * More than 30 days since prior participation in another clinical trial with any investigational drug or device * No other concurrent experimental drugs * No other concurrent systemic anticancer therapy * No concurrent aminoglycoside antibiotics

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-5055, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Beth A. Overmoyer, MD, FACP

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: September 1, 2003
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)