Doxorubicin, Cyclophosphamide, and/or Paclitaxel in Treating Women With Nonmetastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Duke University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00131963

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: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Paclitaxel

U.S. FDA Resources

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

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
Regimen 1: Experimental 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: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV
Regimen 2: Experimental Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.	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 Comprehensive Cancer Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Paul K. Marcom, MD

Duke University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000438673, DUMC-4522-04-1-R1
Study First Received:	August 16, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00131963
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Breast Neoplasms

Cyclophosphamide
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009