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Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: March 8, 2004   Last Updated: July 29, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00079118
  Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: irinotecan hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed tumor response as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event profile [ Designated as safety issue: Yes ]
  • Distribution of progression times [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: April 2004
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • Determine the toxicity profile of this regimen in these patients.
  • Determine the progression-free and overall survival of patients treated with this regimen.

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 CR.

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic disease
  • Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease
  • 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 allowed
    • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • 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

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No myocardial infarction within the past 180 days
  • No congestive heart failure
  • No unstable angina
  • No clinically significant pericardial effusion or arrhythmias

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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)

Radiotherapy

  • See Disease Characteristics
  • At least 30 days since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered

Other

  • More than 7 days since prior parenteral antibiotic therapy
  • No other concurrent experimental drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079118

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Memorial Hospital
Carthage, Illinois, United States, 62321
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States, 52501
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Foote Hospital
Jackson, Michigan, United States, 49201
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
St. John Macomb Hospital
Warren, Michigan, United States, 48093
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
Adult and Pediatric Urology, P.L.L.P.
Sartell, Minnesota, United States, 56377
Brainerd Medical Center
Brainerd, Minnesota, United States, 56401
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, United States, 56265
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Immanuel St. Joseph's Clinic
Mankato, Minnesota, United States, 56002
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Minnesota Oncology Hematology, PA at Maplewood Cancer Center
Maplewood, Minnesota, United States, 55109
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
St. Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Fergus Falls, Minnesota, United States, 56537
Alexandria, Minnesota, United States, 56308
United Hospital
St. Paul, Minnesota, United States, 55102
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, North Dakota
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States, 58501
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58502
United States, Ohio
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Grandview Hospital
Dayton, Ohio, United States, 45405
Kenton Oncology, Incorporated
Kenton, Ohio, United States, 43326
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Toledo Hospital
Toledo, Ohio, United States, 43606
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wisconsin
Central Wisconsin Cancer Program at Agnesian HealthCare
Fond du Lac, Wisconsin, United States, 54935
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
Investigator: Winston Tan, MD, FACP Mayo Clinic
  More Information

Additional Information:
Publications:
Tan WW, Hillman DW, Salim M, Northfelt DW, Anderson DM, Stella PJ, Niedringhaus R, Bernath AM, Gamini SS, Palmieri F, Perez EA. N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group (NCCTG) Trial. Ann Oncol. 2009 Jul 22; [Epub ahead of print]
Tan WW, Hillman D, Salim M, et al.: N0332 phase II trial of weekly irinotecan and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group trial. [Abstract] Breast Cancer Res Treat 106 (1): A-1087, S71-2, 2007.

Study ID Numbers: CDR0000354417, NCCTG-N0332
Study First Received: March 8, 2004
Last Updated: July 29, 2009
ClinicalTrials.gov Identifier: NCT00079118     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Irinotecan
Breast Neoplasms
Enzyme Inhibitors
Camptothecin
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009