Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079118
• Other study ID #: NCCTG-N0332
• Secondary ID: NCI-2012-02579CD
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2004
• Last updated: December 9, 2016
• Start date: April 2004
• Est. completion date: December 2010

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2010
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	McFarland Clinic, PC	Ames	Iowa
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	MeritCare Clinic - Bemidji	Bemidji	Minnesota
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota
United States	Mid Dakota Clinic, P. C.	Bismarck	North Dakota
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Brainerd Medical Center	Brainerd	Minnesota
United States	St. Joseph's Medical Center	Brainerd	Minnesota
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mercy Capitol Hospital	Des Moines	Iowa
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	CCOP - Duluth	Duluth	Minnesota
United States	Miller-Dwan Medical Center	Duluth	Minnesota
United States	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Eureka Community Hospital	Eureka	Illinois
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Medical Group	Fargo	North Dakota
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Central Wisconsin Cancer Program at Agnesian HealthCare	Fond du Lac	Wisconsin
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Mason District Hospital	Havana	Illinois
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Foote Hospital	Jackson	Michigan
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Kenton Oncology, Incorporated	Kenton	Ohio
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Kewanee Hospital	Kewanee	Illinois
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Southwest Medical Center	Liberal	Kansas
United States	Meeker County Memorial Hospital	Lichfield	Minnesota
United States	Lima Memorial Hospital	Lima	Ohio
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	McDonough District Hospital	Macomb	Illinois
United States	Immanuel St. Joseph's Clinic	Mankato	Minnesota
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Minnesota Oncology Hematology, PA at Maplewood Cancer Center	Maplewood	Minnesota
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital System	Monroe	Michigan
United States	Chippewa County - Montevideo Hospital	Montevideo	Minnesota
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois
United States	Ottumwa Regional Health Center Cancer Center	Ottumwa	Iowa
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Reid Hospital & Health Care Services, Incorporated	Richmond	Indiana
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Seton Cancer Institute - Saginaw	Saginaw	Michigan
United States	Coborn Cancer Center	Saint Cloud	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Adult and Pediatric Urology, P.L.L.P.	Sartell	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Saint Francis Cancer Center	Shakopee	Minnesota
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	Siouxland Regional Cancer Center	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	St. Joseph's Hospital	St Paul	Minnesota
United States	CentraCare Clinic - River Campus	St. Cloud	Minnesota
United States	Park Nicollet Health Services	St. Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	St. Paul	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Geisinger Medical Group - Scenery Park	State College	Pennsylvania
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	St. John Macomb Hospital	Warren	Michigan
United States	Fulton County Health Center	Wauseon	Ohio
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota
United States	Woodwinds Health Campus	Woodbury	Minnesota
United States	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Afb	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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 Ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed tumor response as measured by RECIST criteria		Up to 5 years	No
Secondary	Distribution of progression times		Up to 5 years	No
Secondary	Overall survival		Up to 5 years	No