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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00074139
Recruitment Status : Withdrawn (No patients were enrolled)
First Posted : December 11, 2003
Last Update Posted : March 5, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Phase 1

Detailed Description:



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


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 69


  • Female

Menopausal status

  • Not specified

Performance status

  • WHO 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • Neutrophil count at least 2,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL


  • 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


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • 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


  • 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


Biologic therapy

  • Not specified


  • 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


  • Not specified


  • More than 2 weeks since prior major surgery


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00074139

United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT00074139     History of Changes
Other Study ID Numbers: CWRU040314
CDR0000343609 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Case Comprehensive Cancer Center:
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors