Clinical trial NCT00412880: BI 2536 Second Line Monotherapy in SCLC
Official title: An Open-label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 Administered Every 21 Days in Patients With Sensitive Relapse Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Small Cell
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
* Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
* Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.

Exclusion Criteria:

* More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
* Symptomatic brain metastases or leptomeningeal disease
* Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
* Absolute neutrophil count (ANC) \<1,500/µl, platelet count \<100,000/µl, or hemoglobin \<9 mg/dl
* Total bilirubin \>1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) \>2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>5 x ULN in case of known liver metastases, serum creatinine \>2.0 mg/dl (\>176 µmol/L, SI Unit equivalent)
* Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug
* Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug
* Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection
* Known or suspected active drug or alcohol abuse
* Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug
* Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®)
* Patients with neuropathy (sensory or motor) CTCAE 3

Primary outcomes:
measure: Number of Participants With Objective Tumor Response
timeFrame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
measure: Overall Survival
timeFrame: From the start of treatment till death or discontinuation, up to 36 weeks.
measure: Duration of Overall Response
timeFrame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
measure: Occurrence and Intensity of Adverse Events Graded According to CTCAE
timeFrame: From the start of treatment till the last infusion + 21 days, up to 36 weeks.
measure: Number of Participants With Dose Limiting Toxicity
timeFrame: From the start of treatment till the last treatment + 21 days, up to 36 weeks.
measure: Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures
timeFrame: From the start of treatment till the last treatment + 21 days, up to 36 weeks.
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: 1216.11.007 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Chicago
country: United States
facility: 1216.11.003 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evanston
country: United States
facility: 1216.11.006 Boehringer Ingelheim Investigational Site
state: Illinois
city: Boston
country: United States
facility: 1216.11.002 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: 1216.11.005 Boehringer Ingelheim Investigational Site
state: Missouri
city: Chapel Hill
country: United States
facility: 1216.11.001 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: 1216.11.011 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1216.11.010 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Seattle
country: United States
facility: 1216.11.012 Boehringer Ingelheim Investigational Site
state: Washington
city: Edmonton
country: Canada
facility: 1216.11.009 Alberta Cancer Board
state: Alberta
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: