Clinical trial NCT00054275: Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
Official title: A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: recurrent breast cancer
stage IV breast cancer
male breast cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-02-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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 (Eastern Cooperative Oncology Group) 0-2 OR
* Karnofsky 60-100%

Life expectancy

* More than 6 months

Hematopoietic

* WBC(White Blood Count) 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(aspartate aminotransferase)/ALT(alanine aminotransferase) 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

Primary outcomes:
measure: Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
timeFrame: after 6 course (6 months) of combination therapy
Secondary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 3 years
measure: Overall Survival as of 2008
timeFrame: 5 yrs
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Paula Silverman, MD
role: PRINCIPAL_INVESTIGATOR
References: