Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Part of paid clinical trials in Owensboro, Kentucky.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00469898
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Carboplatin dosage calculation to be given on day 1, every 21 days: Carboplatin (mg) = (AUC of 5) x (GFR + 25) \*up to 6 cycles at physician's discretion
  • irinotecan hydrochloride — DRUG
    50 mg/m2 IV on days 1 and 8 every 21 days Should be infused IV over 30- 90 minutes.

Study Details

RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.

Key Dates

Start date
Dec 31, 2003
Status verified
Jul 2012
Primary completion
Jul 31, 2008
Completion
Jul 31, 2010

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Therapeutic Intervention
    Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.

Primary Outcome Measure

Patient Response [ Time Frame: 1.66 months (average duration, on treatment date to best response date) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Owensboro Medical Health SystemOwensboroKentucky42303-
Memorial Health Care SystemChattanoogaTennessee37404-
West Tennessee Cancer Center at Jackson-Madison County General HospitalJacksonTennessee38301-
Tennessee Cancer SpecialistsKnoxvilleTennessee37901-
MBCCOP - Meharry Medical College - NashvilleNashvilleTennessee37208-
St. Thomas Health ServicesNashvilleTennessee37205-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-

Find similar trials in Owensboro, KY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Owensboro Medical Health System· Owensboro, KYMemorial Health Care System· Chattanooga, TNWest Tennessee Cancer Center at Jackson-Madison County General Hospital· Jackson, TNTennessee Cancer Specialists· Knoxville, TNMBCCOP - Meharry Medical College - Nashville· Nashville, TNSt. Thomas Health Services· Nashville, TN

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