Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer
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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 |
- 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.
- 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:
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:
|
|
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:
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:
|
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 |
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| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| 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 May 23, 2013