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Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00003351
Recruitment Status : Completed
First Posted : March 1, 2004
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: irinotecan hydrochloride Phase 2

Detailed Description:

OBJECTIVES: I. Assess the antitumor activity and toxicity of two different schedules of irinotecan in the treatment of patients with refractory metastatic breast cancer who have received 1 or 2 previous chemotherapy regimens (up to one prior therapy for metastatic disease and one for adjuvant therapy). II. Compare the time to progression, survival, and quality of life of these patients on these 2 different schedules of irinotecan.

OUTLINE: This is a randomized study. Patients are stratified according to dominant disease (visceral vs nonvisceral), performance status (0-1 vs 2), and prior chemotherapy in metastatic setting (yes vs no). Patients assigned to arm I 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. Patients assigned to arm II 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.

PROJECTED ACCRUAL: A total of 42-100 patients (21-50 patients per arm) will be accrued for this study within 3.5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Irinotecan (CPT-11) In Patients With Refractory Metastatic Breast Cancer
Study Start Date : August 1998
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm I: irinotecan

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
Experimental: Arm II: irinotecan

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



Primary Outcome Measures :
  1. Time to progression [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: Up to 3 years ]
  2. Quality of life [ Time Frame: Up to 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003351


Locations
Show Show 22 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Edith A. Perez, MD Mayo Clinic
Publications of Results:
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.

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003351    
Other Study ID Numbers: NCCTG-963255
CDR0000066332 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 1, 2004    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents