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Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: December 10, 2003   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00074139
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2003
Detailed Description:

OBJECTIVES:

Primary

  • Determine the pharmacokinetic profile of docetaxel, doxorubicin, and cyclophosphamide in women with advanced breast cancer.

Secondary

  • Compare the pharmacokinetic profile of this regimen in these patients vs the historical pharmacokinetic profile of docetaxel.

OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 followed by doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 22.
  • Arm II: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 1 followed by doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 22. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients may receive additional therapy at the discretion of the treating physician.

Patients are followed at 3-4 weeks.

PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study within 7 months.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074139

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Principal Investigator: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000343609, CWRU-040314, CWRU-AVEN-1103, AVENTIS-XRP6976D/1001
Study First Received: December 10, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00074139     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:
Skin Diseases
Immunologic Factors
Breast Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Recurrence
Doxorubicin
Docetaxel
Anti-Bacterial Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Cyclophosphamide
Antibiotics, Antineoplastic
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

ClinicalTrials.gov processed this record on September 04, 2009