Clinical trial · Interventional
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
NCT00083148CI-TRIAL-00004542completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 capecitabine kill more tumor cells by making tumor cells more sensitive to the drug. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer not eligible for potentially curative therapy or studies of higher priority * Advanced disease * Tumor accessible to biopsy AND not irradiated * Failed at least 1 prior chemotherapy regimen (not including adjuvant chemotherapy) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * AST ≤ 2 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active uncontrolled bacterial, viral, or fungal infection * No poor medical risk from non-malignant systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * Prior irinotecan allowed * Prior carboplatin allowed * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy except for small port radiotherapy for local control Surgery * More than 4 weeks since prior major surgery Other * No concurrent high-dose IV cyclosporine
References
Publications (1)
- RESULTO'connor T, Rustum Y, Levine E, Creaven P. A phase I study of capecitabine and a modulatory dose of irinotecan in metastatic breast cancer. Cancer Chemother Pharmacol. 2008 Jan;61(1):125-31. doi: 10.1007/s00280-007-0456-1. Epub 2007 Apr 11. PMID 17426973