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

Completed · Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT00695292

Run by

SCRI Development Innovations, LLC

People needed

37

Starts

2008-06-01

Expected to finish

2012-09-01

Last updated by the study team

2021-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease.
• Measurable or evaluable disease.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Adequate bone marrow function, as defined by: absolute neutrophil count (ANC) >1,500/µL; platelets >100,000/µL; hemoglobin >=9.0 g/dL.
• 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.
• Resolution of all acute toxic effects of prior therapy or surgical procedures to grade <=1.
• 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.
• Patients must be informed of the investigational nature of this study and sign an informed consent form.
• 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.

You may not qualify if…

• Patients who are pregnant or breastfeeding.
• 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.
• 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.
• Previous treatment with sunitinib.
• 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.
• 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).
• Uncontrolled hypertension (i.e., blood pressure >150 mm Hg that cannot be controlled with standard anti-hypertensive agents).
• 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).
• Patients who have had major surgical procedure, open biopsy, or significant traumatic injury with 28 days (4 weeks) of study initiation.

Where it is running

• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Hospital Cancer Insitute — Orlando, Florida, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• St. Louis Cancer Care — Chesterfield, Missouri, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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