Phase 2
N=17
Carboplatin and Temozolomide (Temodar) for Recurrent and Symptomatic Residual Brain Metastases
Brain Tumor · Brain Metastases
Bottom Line
View on ClinicalTrials.gov: NCT00362817 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide — 42.8 percentage of patients with response
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide |
42.8 | — |
| SECONDARY Analyze Patients Time to Progression |
22.6 | — |
| SECONDARY Determine the Overall Survival of Patients |
25.2 | — |
| SECONDARY Determine the Cause of Death of Patients After Treatment |
0; 7 | — |
| SECONDARY The Incidence and Severity of Centeral Nervous System (CNS) Toxicities |
— | — |
| SECONDARY Quality of Life Assessment |
— | — |
Summary
Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radiation. Survival, causes of death, recurrence of disease in the central nervous system, toxicity, and quality of life will all be measured as secondary objective in this study.
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed systemic cancer
Exclusion Criteria
- Pregnant
- Known CNS meningeal involvement with cancer
Data sourced from ClinicalTrials.gov (NCT00362817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.