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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
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.
Allocation: Randomized, Primary Purpose: Treatment
CCOP - Scottsdale Oncology Program
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:45-0400
This phase I trial studies the side effects and best dose of veliparib when given together with irinotecan hydrochloride in treating patients with cancer that has spread to other parts of ...
RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capeci...
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RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from d...
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Although irinotecan is an important anticancer drug for treating colorectal cancer, its dose-dependent side effects limited its clinical application. Thus, it's important to develop low-toxic candidat...
Irinotecan (CPT-11) in combination with 5-fluorouracil (5FU) is widely used in the treatment of colorectal cancer. We assessed potential clinical variables that may predict toxicity and more specifica...
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Metaplastic breast cancer (MpBC) is a rare but aggressive type of breast cancer accounting for 0.25-1% of all diagnosed invasive breast cancers. Morphologically, it is characterized by differentiation...
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...