NCT00003154

Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Phase II Trial of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) 120-Hour Continuous Intravenous Infusion in Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: I. Determine whether aminocamptothecin colloidal dispersion (AC/CD) administered as a 120 hour weekly infusion is an effective treatment for advanced non-small cell lung cancer. II. Observe any toxicities associated with this treatment in this patient population. OUTLINE: Patients receive a 120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	aminocamptothecin colloidal dispersion	120 hour continuous infusion of aminocamptothecin colloidal dispersion (AC/CD) once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. Treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. Patients are followed every 3 months.

Timeline

• Start date: 1998-01-01
• Primary completion: 2001-04-01
• Completion: 2001-06-01
• First posted: 2004-05-19
• Last updated: 2010-06-10

Locations

1 site across 1 country: United States