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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004182 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer |
Study Start Date: | October 1999 |
OBJECTIVES: I. Determine the objective response rate to irinotecan in patients with metastatic breast cancer who have received prior anthracycline and taxane based chemotherapy for metastatic disease. II. Determine the toxicities of irinotecan in these patients. III. Determine survival time, duration of response, and time to treatment failure in these patients after this therapy.
OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at day 30, then every 3 months.
PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced breast cancer Must have received anthracycline and taxane based chemotherapy for metastatic disease Measurable disease No CNS metastases or carcinomatous meningitis Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1500/mm3 Hemoglobin at least 9.0 g/dL Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.3 mg/dL SGOT no greater than 3 times upper limit of normal (no greater than 5 times ULN if liver involvement) No Gilbert's disease Renal: Creatinine no greater than 2.0 mg/dL Calcium at least 12.0 mg/dL Cardiovascular: No myocardial infarction in the past 6 months No congestive heart failure requiring therapy Other: No active or uncontrolled infection HIV negative No psychiatric disorder that would preclude study No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of seizures No uncontrolled diabetes mellitus (random blood sugar at least 200 mg) No other severe disease that would preclude study Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Greater than 4 weeks since prior chemotherapy No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy No radiotherapy to greater than 30% of bone marrow Surgery: Not specified Other: No concurrent phenytoin, phenobarbitol, or other antiepileptic prophylaxis
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5408 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611 |
Study Chair: | William J. Gradishar, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067421, NU-98B3, P-UPJOHN-976475150, NCI-G99-1642 |
Study First Received: | January 21, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004182 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Irinotecan Breast Neoplasms Antineoplastic Agents, Phytogenic |
Camptothecin Breast Diseases Recurrence |
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Breast Neoplasms Enzyme Inhibitors Camptothecin |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Phytogenic Breast Diseases |