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

NCT00201708 | Completed Phase 2 DMC

• 1 other identifier: OSU-0450
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Adjuvant Trial; Dose-Dense; Axillary Node-Positive

Outcome Measures

Primary Outcomes (1)

• Select one of two adjuvant chemotherapy regimens for evaluation in subsequent phase III trial.

  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.

  up to 8 weeks

Secondary Outcomes (1)

• Determine the toxicities of Docetaxel administered before or after doxorubicin/cyclophosphamide(AC).

  up to 5 years

Study Arms (2)

Arm A (Docetaxel before doxorubicin/cyclophosphamide)

ACTIVE COMPARATOR

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; Drug: Doxorubicin; Drug: Cyclophosphamide (AC)

Arm B (Docetaxel after doxorubicin/cyclophosphamide)

ACTIVE COMPARATOR

"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; Drug: Doxorubicin; Drug: Cyclophosphamide (AC)

Interventions

Docetaxel DRUG

Arm A:75 mg/m2 every 2 weeks)for 4 cycles. Arm B:75 mg/m2 every 2 weeks for 4 cycles.

Also known as: Taxotere

Arm A (Docetaxel before doxorubicin/cyclophosphamide); Arm B (Docetaxel after doxorubicin/cyclophosphamide)

Doxorubicin DRUG

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)

Also known as: Adriamycin, hydroxydaunorubicin

Arm A (Docetaxel before doxorubicin/cyclophosphamide); Arm B (Docetaxel after doxorubicin/cyclophosphamide)

Cyclophosphamide (AC) DRUG

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)

Also known as: Cytoxan, CPM, CTX, CYT

Arm A (Docetaxel before doxorubicin/cyclophosphamide); Arm B (Docetaxel after doxorubicin/cyclophosphamide)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Puhalla S, Mrozek E, Young D, Ottman S, McVey A, Kendra K, Merriman NJ, Knapp M, Patel T, Thompson ME, Maher JF, Moore TD, Shapiro CL. Randomized phase II adjuvant trial of dose-dense docetaxel before or after doxorubicin plus cyclophosphamide in axillary node-positive breast cancer. J Clin Oncol. 2008 Apr 1;26(10):1691-7. doi: 10.1200/JCO.2007.14.3941. Epub 2008 Mar 3.

  PMID: 18316792 BACKGROUND

Related Links

• Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Charles Shapiro, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: October 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2014
• Last Updated: September 2, 2016

Record last verified: 2016-09

Locations

US (1)