Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00695292
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • irinotecan — DRUG
    irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15
  • Carboplatin — DRUG
    carboplatin AUC=4 on Day 1
  • sunitinib — DRUG
    sunitinib 25 mg orally (PO) daily after initial chemotherapy

Study Details

This proposed Phase II trial will investigate the combination of irinotecan and carboplatin followed by sunitinib in the first-line treatment of patients with extensive-stage SCLC.

Key Dates

Start date
Jun 30, 2008
Status verified
Nov 2021
Primary completion
Jun 30, 2011
Completion
Sep 30, 2012

Study Design

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

Arms

  • Experimental: Intervention
    Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs. Re-staging will be performed every 2 cycles (every 8 weeks) during the study.

Primary Outcome Measure

One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment [ Time Frame: 18 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Florida Hospital Cancer InsituteOrlandoFlorida32804-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Baton Rouge General Medical CenterBaton RougeLouisiana70806-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
St. Louis Cancer CareChesterfieldMissouri63017-
Oncology Hematology CareCincinnatiOhio45242-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Fort Myers, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Florida Cancer Specialists· Fort Myers, FLFlorida Hospital Cancer Insitute· Orlando, FLNortheast Georgia Medical Center· Gainesville, GABaton Rouge General Medical Center· Baton Rouge, LACenter for Cancer and Blood Disorders· Bethesda, MDSt. Louis Cancer Care· Chesterfield, MO

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