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Phase II Study of Erlotinib and Docetaxel in Patients With Stage IV or Recurrent Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry CASE-CWRU-070214
CASE-CWRU-1102, NCT00054275

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.

Entry 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

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

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/mm³
Platelet count at least 100,000/mm³
Absolute neutrophil count at least 1,500/mm³
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

Expected Enrollment

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

Outcomes

Primary Outcome(s)

Disease response measured after every 2 courses

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.

Trial Contact Information

Trial Lead Organizations

Case Comprehensive Cancer Center

Paula Silverman, MD, Protocol chair
Ph: 216-844-8510
Email: pxs7@case.edu

Registry Information

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

Trial Start Date		2002-12-04

Registered in ClinicalTrials.gov		NCT00054275

Date Submitted to PDQ		2002-12-23

Information Last Verified		2006-12-03

NCI Grant/Contract Number		CA43703

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.