Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

NCT00079118 | Completed Phase 2

• 3 other identifiers: NCCTG-N0332NCI-2012-02579CDR0000354417
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 162

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Confirmed tumor response as measured by RECIST criteria

  Up to 5 years

Secondary Outcomes (2)

• Distribution of progression times

  Up to 5 years

• Overall survival

  Up to 5 years

Study Arms (1)

docetaxel + irinotecan

EXPERIMENTAL

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.

Drug: docetaxel; Drug: irinotecan hydrochloride

Interventions

docetaxel DRUG

docetaxel + irinotecan

irinotecan hydrochloride DRUG

docetaxel + irinotecan

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (162)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, 47374, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

Ottumwa Regional Health Center Cancer Center

Ottumwa, Iowa, 52501, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Hospital

Jackson, Michigan, 49201, United States

Location

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, 48144, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48909, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital System

Monroe, Michigan, 48162, United States

Location

Seton Cancer Institute - Saginaw

Saginaw, Michigan, 48601, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Unknown Facility

Alexandria, Minnesota, 56308, United States

Location

MeritCare Clinic - Bemidji

Bemidji, Minnesota, 56601, United States

Location

Brainerd Medical Center

Brainerd, Minnesota, 56401, United States

Location

St. Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller-Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Unknown Facility

Fergus Falls, Minnesota, 56537, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Lichfield, Minnesota, 55355, United States

Location

Immanuel St. Joseph's Clinic

Mankato, Minnesota, 56002, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology Hematology, PA at Maplewood Cancer Center

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Chippewa County - Montevideo Hospital

Montevideo, Minnesota, 56265, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Adult and Pediatric Urology, P.L.L.P.

Sartell, Minnesota, 56377, United States

Location

Saint Francis Cancer Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Woodwinds Health Campus

Woodbury, Minnesota, 55125, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Cancer Care Center at Medcenter One Hospital

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, P. C.

Bismarck, North Dakota, 58501, United States

Location

St. Alexius Medical Center

Bismarck, North Dakota, 58502, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Medical Group

Fargo, North Dakota, 58122, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Kenton Oncology, Incorporated

Kenton, Ohio, 43326, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

United States Air Force Medical Center - Wright-Patterson

Wright-Patterson AFB, Ohio, 45433-5529, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Central Wisconsin Cancer Program at Agnesian HealthCare

Fond du Lac, Wisconsin, 54935, United States

Location

Related Publications (1)

• 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. 2010 Mar;21(3):493-497. doi: 10.1093/annonc/mdp328. Epub 2009 Jul 22.

  PMID: 19625343 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Docetaxel; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Edith A. Perez, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: April 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: December 1, 2010
• Last Updated: December 13, 2016

Record last verified: 2016-12

Locations

US (162)