Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Ohio State University Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201708
First received: September 12, 2005
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Doxorubicin
Drug: Cyclophosphamide (AC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide (AC) in Axillary Node-Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial. [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
    Docetaxel before doxorubicin/cyclophosphamide(AC)or Docetaxel after AC. The regimen selection will be based on the proportion of patients receiving four cycles of Docetaxel with no dose reductions within 10 weeks.


Secondary Outcome Measures:
  • Determine the toxicities of Docetaxel administered before or after doxorubicin/cyclophosphamide(AC). [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: October 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A (Docetaxel before doxorubicin/cyclophosphamide)
Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.
Drug: Docetaxel
Arm A:75 mg/m2 every 2 weeks)for 4 cycles. Arm B:75 mg/m2 every 2 weeks for 4 cycles.
Other Name: Taxotere
Drug: Doxorubicin
60 mg/m2 intravenously as push over 2-5 minutes, every 14 days for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide) , Arm B (Docetaxel after doxorubicin/cyclophosphamide)
Other Names:
  • Adriamycin
  • hydroxydaunorubicin
Drug: Cyclophosphamide (AC)
600 mg/m2 over 30 to 60 minutes every 14 days (2 weeks) for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide)
Other Names:
  • Cytoxan
  • CPM
  • CTX
  • CYT
Active Comparator: Arm B (Docetaxel after doxorubicin/cyclophosphamide)
"A" (doxorubicin) 60 mg/m2 & "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.
Drug: Docetaxel
Arm A:75 mg/m2 every 2 weeks)for 4 cycles. Arm B:75 mg/m2 every 2 weeks for 4 cycles.
Other Name: Taxotere
Drug: Doxorubicin
60 mg/m2 intravenously as push over 2-5 minutes, every 14 days for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide) , Arm B (Docetaxel after doxorubicin/cyclophosphamide)
Other Names:
  • Adriamycin
  • hydroxydaunorubicin
Drug: Cyclophosphamide (AC)
600 mg/m2 over 30 to 60 minutes every 14 days (2 weeks) for 4 cycles. Arms: Arm A (Docetaxel before doxorubicin/cyclophosphamide), Arm B (Docetaxel after doxorubicin/cyclophosphamide)
Other Names:
  • Cytoxan
  • CPM
  • CTX
  • CYT

Detailed Description:

Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to administer these treatments remains unknown. The current study assesses two separate sequences of docetaxel, doxorubicin, and cyclophosphamide.

Purpose: This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer. Combination one is docetaxel before doxorubicin and cyclophosphamide. Combination two is docetaxel after doxorubicin and cyclophosphamide. The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study. The toxicities of docetaxel will also be assessed in study participants.

Treatment: Patients in this study will receive one of two chemotherapy combination schedules. A computer will randomly assign patients into their treatment group. Group one will receive docetaxel before doxorubicin and cyclophosphamide. Group two will receive docetaxel after doxorubicin and cyclophosphamide.

Patients in group one will receive docetaxel every two weeks for a total of eight weeks. These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. These patients will then be given docetaxel every two weeks for a total of eight weeks.

Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have histologically or cytologically confirmed breast cancer
  • No metastatic disease
  • Prior lumpectomy or mastectomy
  • No prior chemotherapy or hormone treatments for breast cancer
  • Must have normal organ and marrow function.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclusion Criteria:

  • Peripheral neuropathy of grade II or higher.
  • History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
  • History of unstable angina or myocardial infarction within the last six months.
  • Pregnant or nursing women.
  • Known allergies to polysorbate 80.
  • HIV-positive patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201708

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Charles Shapiro Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201708     History of Changes
Other Study ID Numbers: OSU-0450
Study First Received: September 12, 2005
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Adjuvant Trial
Dose-Dense
Axillary Node-Positive

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

ClinicalTrials.gov processed this record on July 22, 2014