Trials / Completed
CompletedNCT00010218
Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · 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 karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer
Detailed description
OBJECTIVES: * Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy. * Determine the effect of prior response to chemotherapy on response to this drug in these patients. * Determine survival and failure-free survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients. OUTLINE: Patients are stratified according to response to prior chemotherapy (relapsed vs refractory). Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A minimum of 45 patients (25 for stratum I and 20 for stratum II) will be accrued for this study within 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | karenitecin |
Timeline
- Start date
- 2001-04-01
- Primary completion
- 2003-04-01
- Completion
- 2006-01-01
- First posted
- 2003-01-27
- Last updated
- 2016-07-19
Locations
44 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00010218. Inclusion in this directory is not an endorsement.