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

1. 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.
2. Determine time to tumor progression in patients treated with this regimen.
3. 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

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

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