Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00132054
- Lead Sponsor
- Japan Multinational Trial Organization
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, 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 I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer.
Secondary
* Determine the response rate in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the frequency and severity of adverse events in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of amrubicin.
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1/3 (or 33%) of patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Osaka Police Hospital
🇯🇵Osaka City, Japan
Osaka Kosei Nenkin Hospital
🇯🇵Osaka, Japan
Kitano Hospital
🇯🇵Osaka, Japan
National Hospital Organization - Osaka National Hospital
🇯🇵Osaka, Japan
Gunma Cancer Center
🇯🇵Gunma, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
National Hospital Organization - Dohoku National Hospital
🇯🇵Hokkaido, Japan