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NCT00079118

Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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stage IV breast cancer recurrent breast cancer male breast cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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docetaxel + irinotecan

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.

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

irinotecan hydrochloride

Intervention Type DRUG

Interventions

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docetaxel

Intervention Type DRUG

irinotecan hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edith A. Perez, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

St. Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status