NCT00003351

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of irinotecan in treating patients who have refractory metastatic breast cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Aug 1998

Longer than P75 for phase_2 breast-cancer

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

March 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

8.2 years

First QC Date

November 1, 1999

Last Update Submit

July 12, 2016

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Time to progression

    Up to 3 years

Secondary Outcomes (2)

  • Survival

    Up to 3 years

  • Quality of life

    Up to 3 years

Study Arms (2)

Arm I: irinotecan

EXPERIMENTAL

Patients receive irinotecan intravenously over 90 minutes every week for 4 weeks followed by a 2 week rest period. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are followed every 3 months for 2 years, then annually for 1 year.

Drug: irinotecan hydrochloride

Arm II: irinotecan

EXPERIMENTAL

Patients receive irinotecan intravenously over 90 minutes every 3 weeks for 6 weeks. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are followed every 3 months for 2 years, then annually for 1 year.

Drug: irinotecan hydrochloride

Interventions

irinotecan hydrochlorideDRUG
Arm I: irinotecanArm II: irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast with progressing locoregional or metastatic disease Measurable or evaluable indicator lesion No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 0.3 mg/dL above upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 1.0 mg/dL above ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: No uncontrolled infection No chronic debilitating disease Not pregnant or lactating Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy No more than 2 prior chemotherapy regimens for metastatic disease No more than 1 prior chemotherapy regimen in the adjuvant setting At least 1 prior regimen containing taxane or doxorubicin for metastatic disease or in the adjuvant setting Endocrine therapy: Not specified Radiotherapy: No radiotherapy to greater than 25% of bone marrow No prior treatment with strontium 89 Surgery: At least 4 weeks since major surgery Other: No concurrent metoclopramide

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

Sponsors & Collaborators

Study Sites (22)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

  • Perez EA, Hillman DW, Milliard JA, et al.: Randomized phase II study of 2 schedules of irinotecan (CPT-11) for patients (pts) with refractory metastatic breast cancer (MBC): an NCCTG Cooperative Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-206, 2002.

    RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Edith A. Perez, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 1, 2004

Study Start

August 1, 1998

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

CA(1)US(21)