Clinical trial · Interventional
Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases
A Phase II Study of Irinotecan and Temozolomide in Breast Cancer Patients With Brian Metastases That Have Progressed After Stereotactic Radiosurgery or Whole Brain Radiation
NCT00617539CI-TRIAL-00032605completedPhase 2Results postedClinicalTrials.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 temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with temozolomide and to see how well it works in treating patients with breast cancer who have received previous treatment for brain metastases.
Conditions
Conditions (2)
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 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan and temozolomide
- interventionNames
- Drug: irinotecan hydrochloride
- Drug: temozolomide
Primary outcomes (2)
- measure
- Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS
- timeFrame
- Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years
- description
- Imaging was performed at 8-week intervals to assess response to treatment. Patients with known or suspected leptomeningeal disease were deemed to have a complete response if CSF cytology converted to negative (if positive at baseline) and all meningeal enhancement or nodularity of brain and/or spine MRI resolved. A modified RECIST 1.0 criteria was used to assess CNS response for patients with new or progressing brain metastases. In this modified RECIST criteria, CNS lesions \<1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions \<1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer with radiographically confirmed metastases to the brain * Extracranial metastases allowed * Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following: * External beam radiotherapy * Brachytherapy * Stereotactic radiosurgery * Surgery * Chemotherapy * Treatments with investigational drugs, biologics, or devices * Disease progression in the CNS must meet ≥ 1 of the following criteria: * New lesions in the CNS on an imaging study (contrast-enhanced CT scan or MRI) * Progressive lesions on an imaging study (contrast-enhanced CT scan or MRI) * New or progressive lesions that do not meet measurable disease definition allowed * Leptomeningeal disease allowed if concurrent progression or parenchymal brain metastases * Not a candidate for surgical resection and/or further stereotactic radiosurgery * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-2 * Life expectancy ≥ 1 month * Hemoglobin ≥ 10 g/dL (transfusion allowed) * ANC ≥ 1,500/mm³ * Granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 mg/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN * Must be able to swallow and retain oral medications * No other active malignancy except for any of the following: * Curatively treated basal or squamous cell carcinoma of the skin * Carcinoma in situ of the cervix * Other malignancies considered disease-free * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of immediate or delayed-type hypersensitivity reaction to gadolinium contrast agents or other contraindication to gadolinium contrast * No other known contraindication to MRI including, but not limited to, any of the following: * Cardiac pacemaker * Implanted cardiac defibrillator * Brain aneurysm clips * Cochlear implant * Ocular foreign body * Shrapnel * No active or uncontrolled infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from the side effects of prior chemotherapy, surgery, or radiotherapy for extracranial disease or brain metastases * Concurrent trastuzumab, bisphosphonate, and/or corticosteroid therapy allowed * At least 1 week since prior or on current stable dose of corticosteroid therapy * Patients on an enzyme-inducing anti-epileptic agent (EIAE) or valproic acid are eligible if they are switched to an alternate non-EIAE medication * Concurrent coumadin allowed * No prophylactic use of filgrastim (G-CSF) during first course of treatment
References
Publications (0)
Data not yet available
No reference posted for this study.