Trials / Unknown
UnknownNCT00014547
BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
Phase II Study Of BBR 3464 As Treatment In Patients With Sensitive Or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Theradex · Industry
- 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 BBR 3464 in treating patients who have metastatic small cell lung cancer that has not responded to previous treatment.
Detailed description
OBJECTIVES: I. Determine the efficacy of BBR 3464 in terms of response rate in patients with sensitive or refractory metastatic small cell lung cancer. II. Determine the duration of response and time to progression in patients treated with this drug. III. Determine the overall survival of patients treated with this drug. IV. Determine the incidence and severity of toxic effects of this drug in this patient population. V. Determine the pharmacokinetics of this drug in this patient population. OUTLINE: This is a multicenter study. Patients are stratified according to disease (refractory vs sensitive). Patients receive BBR 3464 IV over 1 hour on day 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease may receive up to 6 courses of therapy. Patients without progressive disease after 6 courses may continue treatment at the investigator's discretion. Patients are followed every 9 weeks for 3 years. PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BBR 3464 |
Timeline
- Start date
- 2000-11-01
- First posted
- 2004-03-11
- Last updated
- 2008-07-24
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00014547. Inclusion in this directory is not an endorsement.