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A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer


- Determine the anti-tumor activity of erlotinib and gemcitabine in patients with
metastatic breast cancer previously treated with anthracycline and/or taxane.

- Determine the adverse event profile of this regimen in these patients.

- Determine whether epidermal growth factor receptor and HER-2 receptor intensity and
serum concentrations have an impact on clinical response in patients treated with this

- Determine the impact of genetic differences in proteins involved in drug response
(transport, metabolism, and mechanism of action) on clinical response and adverse
events associated with gemcitabine in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV on days 1 and 8 and oral erlotinib on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients achieving a complete response are followed every 6 weeks for up to 5 years or until
disease progression (PD). Patients discontinuing study therapy for any other reason are
followed every 3 months until PD and then every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 5-56 patients will be accrued for this study within 20 months.

Inclusion Criteria


- Histologically or cytologically confirmed breast cancer

- Clinical evidence of metastatic disease

- Candidate for first- or second-line chemotherapy for metastatic disease

- Must have received prior anthracycline or taxane therapy (may have had both in the
neoadjuvant, adjuvant, or metastatic setting)

- At least 1 measurable lesion at least 20 mm by CT scan or MRI OR at least 10 mm by
spiral CT scan

- The following are not considered measurable disease:

- Small lesions less than 20 mm by CT scan or MRI

- Bone lesions

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- No active CNS metastases (treated CNS metastases stable for more than 8 weeks are

- Hormone receptor status:

- Not specified



- 18 and over


- Male or female

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8.5 g/dL


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 3 times ULN

- Alkaline phosphatase no greater than 3 times ULN


- Creatinine no greater than 1.5 times ULN


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- No inability to take oral or nasogastric medication

- No requirement for IV alimentation

- No active peptic ulcer disease


- No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjögren's

- No congenital abnormality (e.g., Fuch's dystrophy)

- No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or

- No abnormal corneal sensitivity test (Schirmer test or similar tear production test)


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Sub-dermal implants and condoms are not considered acceptable forms of

- No other invasive non-breast malignancy within the past 5 years except adequately
treated basal cell or squamous cell skin cancer

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other concurrent uncontrolled illness


Biologic therapy

- At least 2 weeks since prior immunotherapy

- No prior cetuximab


- At least 2 weeks since prior chemotherapy and recovered

- No more than 1 prior chemotherapy regimen for metastatic disease

- No more than 2 prior chemotherapy regimens total, including adjuvant therapy

Endocrine therapy

- Prior hormonal therapy allowed in metastatic and/or adjuvant setting


- At least 2 weeks since prior radiotherapy

- No prior radiotherapy to more than 25% of bone marrow

- No prior strontium chloride Sr 89


- More than 4 weeks since prior major surgery

- No prior surgical procedures affecting absorption


- No prior epidermal growth factor receptor-targeting therapies (e.g., gefitinib or

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent antitumor therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

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



Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Dayton Kettering, Ohio  45429
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
CCOP - Oklahoma Tulsa, Oklahoma  74136
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Medcenter One Health System Bismarck, North Dakota  58501
CentraCare Health Plaza Saint Cloud, Minnesota  56303
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259