Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054275

Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: docetaxel Drug: erlotinib hydrochloride	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Erlotinib Erlotinib hydrochloride Epidermal Growth Factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With Ther Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer

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

Primary Outcome Measures:

Disease response measured after every 2 courses [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2002

Detailed Description:

OBJECTIVES:

Determine the antitumor effects of erlotinib and docetaxel, in terms of objective response, stabilization of disease, and progression-free survival, in patients with stage IV or recurrent breast cancer.
Determine time to tumor progression in patients treated with this regimen.
Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib.

OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage IV or recurrent adenocarcinoma of the breast
Measurable disease
Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel
Stable brain metastases allowed
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Male or female

Menopausal status

Not specified

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

More than 6 months

Hematopoietic

WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Hemoglobin at least 8 g/dL

Hepatic

Bilirubin normal
AST/ALT no greater than 2.5 times upper limit of normal

Renal

Creatinine normal OR
Creatinine clearance at least 60 mL/min
No clinically significant proteinuria
No significant impairment of renal function

Cardiovascular

No New York Heart Association class III or IV heart disease
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No inadequately controlled hypertension

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80
No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer
No ongoing or active infection
No peripheral neuropathy greater than grade 1
No other concurrent uncontrolled medical condition that would preclude study participation
No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior trastuzumab (Herceptin) allowed

Chemotherapy

See Disease Characteristics
No prior chemotherapy for recurrent or metastatic disease
Prior adjuvant chemotherapy allowed

Endocrine therapy

Prior hormonal therapy allowed

Radiotherapy

Not specified

Surgery

Not specified

Other

No other concurrent investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054275

Locations

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Paula Silverman, MD

Case Comprehensive Cancer Center

More Information

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

Study ID Numbers:	CDR0000270200, CASE-CWRU-070214, CASE-CWRU-1102
Study First Received:	February 5, 2003
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00054275
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage IV breast cancer
male breast cancer

Study placed in the following topic categories:

Erlotinib
Docetaxel
Skin Diseases
Breast Neoplasms, Male

Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009