Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003154|
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 10, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: aminocamptothecin colloidal dispersion||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) 120-Hour Continuous Intravenous Infusion in Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||January 1998|
|Actual Primary Completion Date :||April 2001|
|Actual Study Completion Date :||June 2001|
Drug: aminocamptothecin colloidal dispersion
- Study the effectiveness of aminocamptothecin in treating patients with stage III or stage IV non-small cell lung cancer. [ Time Frame: 120 hour continuous infusion once a week for 2 weeks, followed by 1 week of rest. Patients are assessed after every 2 courses of therapy. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003154
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Nathan Levitan, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|