Trials / Terminated
TerminatedNCT00087048
Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.
Detailed description
OBJECTIVES: Primary * Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride. Secondary * Determine the safety and toxic effects of this drug in these patients. * Determine the recurrence-free survival of patients treated with this drug. * Determine time to response and tumor response in patients treated with this drug. * Determine the quality of life of patients treated with this drug. OUTLINE: This is a non-randomized, multicenter study. Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter. Patients are followed at 7-14 days and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | topotecan hydrochloride |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2006-02-01
- Completion
- 2006-02-01
- First posted
- 2004-07-12
- Last updated
- 2016-03-22
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00087048. Inclusion in this directory is not an endorsement.