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Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer



- Determine the antitumor activity of irinotecan and docetaxel, in terms of response
rate, in patients with refractory metastatic breast cancer.


- Determine the toxicity profile of this regimen in these patients.

- Determine the progression-free and overall survival of patients treated with this

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1
and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond

Patients are followed every 2 months until disease progression and then every 6 months

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 20 months.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the breast

- Metastatic disease

- Previously treated with chemotherapy in the adjuvant setting and/or for metastatic

- At least one unidimensionally measurable lesion

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

- Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are

- Lesions on chest x-ray are allowed provided they are clearly defined and
surrounded by aerated lung

- The following are not considered measurable:

- Bone lesions

- Ascites

- Leptomeningeal disease

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Cystic lesions

- No known CNS metastases unless controlled by prior surgery and/or radiotherapy

- Hormone receptor status:

- Estrogen receptor (ER) and/or progesterone receptor (PR) status known



- 18 and over


- Male or female

Menopausal status

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months


- Granulocyte count ≥ 1,500/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ upper limit of normal (ULN)

- Meets 1 of the following criteria:

- AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN

- Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN

- AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ 1.5 times ULN


- No myocardial infarction within the past 180 days

- No congestive heart failure

- No unstable angina

- No clinically significant pericardial effusion or arrhythmias


- No active, unresolved infection

- No prior severe hypersensitivity reaction to docetaxel, irinotecan, or any drug
formulated with polysorbate 80

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No grade 1 or greater sensory or motor neuropathy

- No other concurrent severe condition that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy

- Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless


- See Disease Characteristics

- More than 14 days since prior chemotherapy

- No more than 2 prior chemotherapy regimens for metastatic disease

- No prior irinotecan or docetaxel for metastatic disease

- Docetaxel as adjuvant therapy allowed

- No other concurrent chemotherapy

Endocrine therapy

- Prior hormonal therapy required for patients with ER- and/or PR-positive tumors
(unless contraindicated)


- See Disease Characteristics

- At least 30 days since prior radiotherapy

- No concurrent radiotherapy


- See Disease Characteristics

- At least 3 weeks since prior major surgery and recovered


- More than 7 days since prior parenteral antibiotic therapy

- No other concurrent experimental drugs

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed tumor response as measured by RECIST criteria

Safety Issue:


Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

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



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Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
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Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
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Methodist Medical Center of Illinois Peoria, Illinois  61636
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John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
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Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
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St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
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Community Cancer Center Normal, Illinois  61761
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Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
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Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
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MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
Brainerd Medical Center Brainerd, Minnesota  56401
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Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Chippewa County - Montevideo Hospital Montevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
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MeritCare Medical Group Fargo, North Dakota  58122
Wood County Oncology Center Bowling Green, Ohio  43402
Samaritan North Cancer Care Center Dayton, Ohio  45415
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UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
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Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Miller-Dwan Medical Center Duluth, Minnesota  55805
Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Adult and Pediatric Urology, P.L.L.P. St. Cloud, Minnesota  56303
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Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Flower Hospital Cancer Center Sylvania, Ohio  43560
Immanuel St. Joseph's Clinic Mankato, Minnesota  56002
Woodwinds Health Campus Woodbury, Minnesota  55125
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Minnesota Oncology Hematology, PA at Maplewood Cancer Center Maplewood, Minnesota  55109
Ottumwa Regional Health Center Cancer Center Ottumwa, Iowa  52501
Central Wisconsin Cancer Program at Agnesian HealthCare Fond du Lac, Wisconsin  54935