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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00695292
First received: June 9, 2008
Last updated: February 22, 2013
Last verified: February 2013

June 9, 2008
February 22, 2013
June 2008
June 2011   (final data collection date for primary outcome measure)
One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To evaluate the time to progression in patients with extensive-stage SCLC treated with irinotecan, carboplatin, and sunitinib. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00695292 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.
  • Efficacy and Safety Analysis Will be Conducted in Patients With Progressive Disease or Irreversible Toxicity on Chemotherapy Alone Who Elect to Receive Sunitinib Alone Until Progressive Disease or Irreversible Toxicity. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To evaluate the objective response rate, overall toxicity, and overall survival in patients with extensive-stage SCLC treated with irinotecan, carboplatin, and sunitinib. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
Phase II Study of Irinotecan, Carboplatin, and Sunitinib in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer

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.

Irinotecan/platinum regimens are emerging as standard treatments for patients with extensive-stage disease. The irinotecan/carboplatin doses that will be used in this study have been used in two previous Phase II SCLC trials, and were found to be extremely well tolerated (Thompson et al. 2005; Spigel et al. 2007). Adding a novel, minimally toxic agent to this regimen may further enhance efficacy in this patient population without contributing to toxicity. This trial will evaluate the use of sunitinib following 6 cycles of treatment with chemotherapy in the treatment of SCLC.

The trial will be performed under the leadership of SCRI, a community-based, multi-center, clinical trial organization.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: irinotecan
    irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15
    Other Name: Camptosar
  • Drug: Carboplatin
    carboplatin AUC=4 on Day 1
    Other Name: Paraplatin
  • Drug: sunitinib
    sunitinib 25 mg orally (PO) daily after initial chemotherapy
    Other Name: Sutent
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.

Interventions:
  • Drug: irinotecan
  • Drug: Carboplatin
  • Drug: sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2012
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease.
  2. Measurable or evaluable disease.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  4. Adequate bone marrow function, as defined by: absolute neutrophil count (ANC) >1,500/µL; platelets >100,000/µL; hemoglobin >=9.0 g/dL.
  5. Normal organ function, defined as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 × the upper limit of normal (ULN), or AST and ALT <=5 × the ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin <=1.5 × the ULN; serum creatinine <=1.5 × the ULN.
  6. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade <=1.
  7. Women of childbearing potential and men with partners of childbearing potential must agree to use a form of birth control that is acceptable to their physician to prevent pregnancy during treatment.
  8. Patients must be informed of the investigational nature of this study and sign an informed consent form.
  9. Patients who have treated brain metastases >=4 weeks out (with surgery and/or radiation therapy) and who have no evidence of central nervous system (CNS) progression. Steroid use should be discontinued before study treatment begins.

Exclusion Criteria:

  1. Patients who are pregnant or breastfeeding.
  2. Patients may not have received other agents (either investigational or marketed) which act by anti-angiogenic mechanisms. Angiogenesis inhibitors include (but are not limited to): thalidomide, sorafenib, bevacizumab.
  3. Patients who have had previous chemotherapy or radiation therapy for extensive-stage disease will be excluded. Palliative radiation (e.g., for bone disease) or radiation for cranial metastasis is acceptable if the patient has recovered from any adverse effects.
  4. Previous treatment with sunitinib.
  5. Myocardial infarction, severe or unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (CHF), cerebrovascular accident (including transient ischemic attack), or pulmonary embolism within 6 months prior to study initiation.
  6. Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >=2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec (for males) or >470 msec (for females).
  7. Uncontrolled hypertension (i.e., blood pressure >150 mm Hg that cannot be controlled with standard anti-hypertensive agents).
  8. Active brain metastasis. (Patients who had brain metastases treated with radiation or surgery and have no evidence of progressive brain metastases at least 4 weeks later are eligible).
  9. Patients who have had major surgical procedure, open biopsy, or significant traumatic injury with 28 days (4 weeks) of study initiation.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00695292
SCRI LUN 156
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Pfizer
Study Chair: David R Spigel, M.D. SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP