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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000

Outcome Description:

Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.

Outcome Time Frame:

after 6 course (6 months) of combination therapy

Safety Issue:

No

Principal Investigator

Paula Silverman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CWRU1102

NCT ID:

NCT00054275

Start Date:

December 2002

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065