Doxorubicin, Cyclophosphamide, and/or Paclitaxel in Treating Women With Nonmetastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00131963
First received: August 16, 2005
Last updated: December 7, 2011
Last verified: April 2008
  Purpose

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or paclitaxel work in treating women with nonmetastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pharmacogenomics of doxorubicin, cyclophosphamide, and paclitaxel [ Designated as safety issue: No ]
  • Treatment-induced myelosuppression (e.g., neutropenia) [ Designated as safety issue: No ]
  • Incidence of peripheral neuropathy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (relapse in adjuvant setting) for 10 years after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2003
Arms Assigned Interventions
Experimental: Regimen 1
Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
Drug: AC regimen
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Experimental: Regimen 2
Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.
Drug: AC regimen
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: paclitaxel
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and cyclophosphamide and/or paclitaxel in women with nonmetastatic invasive breast cancer.
  • Determine treatment-induced myelosuppression (e.g., neutropenia) in patients treated with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug activation and metabolism genes.
  • Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in patients treated with paclitaxel.

Secondary

  • Determine response (i.e., relapse in the adjuvant setting) during a 10-year follow-up period in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients receive treatment on CALGB-40101 OR are assigned to receive 1 of 2 treatment regimens on this study.

  • Regimen 1: Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
  • Regimen 2: Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.

After completion of study treatment, patients are followed at 3, 6, and 12 months and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 500 patients (300 treated with doxorubicin and cyclophosphamide and 200 treated with paclitaxel) will be accrued for this study within 3-4 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:

    • Node negative disease AND meets 1 of the following stage criteria:

      • Primary tumor > T1c
      • Primary tumor > T1b AND poor prognostic features, defined as the following:

        • High-grade disease
        • HER2/neu-positive disease by fluorescence in situ hybridization
        • Estrogen receptor-negative disease
      • Stage II disease (T2, N0)
    • Node positive nonmetastatic disease
    • Locally advanced disease AND receiving neoadjuvant chemotherapy comprising doxorubicin and cyclophosphamide OR paclitaxel
    • Enrolled in clinical trial CALGB-40101
  • No evidence of systemic metastasis
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 2.0 times upper limit of normal

Renal

  • Creatinine < 2.0 mg/dL

Cardiovascular

  • No ischemic heart disease
  • No uncontrolled hypertension

Other

  • Not pregnant
  • No poorly controlled diabetes mellitus
  • No active infection
  • No peripheral neuropathy ≥ grade 2
  • No other serious comorbidity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent anticancer immunotherapy or biologic response modifiers
  • No concurrent growth factors during course 1 of doxorubicin and cyclophosphamide study treatment

Chemotherapy

  • See Disease Characteristics
  • No prior weekly paclitaxel

Endocrine therapy

  • No concurrent anticancer endocrine therapy

Radiotherapy

  • Concurrent radiotherapy to the chest wall allowed for patients receiving paclitaxel only

Surgery

  • At least 2 weeks since prior major surgery (e.g., wide excision, lumpectomy, or mastectomy)

Other

  • More than 2 weeks since prior and no concurrent CYP450 inducers or inhibitors
  • No other concurrent anticancer cytotoxic therapy
  • No other concurrent investigational drugs
  • No other concurrent medications known to cause myelosuppression (e.g., neutropenia) or neuropathy
  • No concurrent participation in another clinical trial except for patients receiving adjuvant doxorubicin and cyclophosphamide on protocols CALGB-40101 or MA-21
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131963

Locations
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Cancer Institute    888-275-3853      
Sponsors and Collaborators
Duke Cancer Institute
Investigators
Principal Investigator: Paul K. Marcom, MD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00131963     History of Changes
Other Study ID Numbers: CDR0000438673, DUMC-4522-04-1-R1
Study First Received: August 16, 2005
Last Updated: December 7, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Paclitaxel
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 15, 2014