Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: irinotecan; Carboplatin; sunitinib
Intervention description: irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15; carboplatin AUC=4 on Day 1; sunitinib 25 mg orally (PO) daily after initial chemotherapy
Intervention MeSH terms: Carboplatin; Irinotecan; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Small Cell Lung Cancer; Extensive Stage; irinotecan; carboplatin; sunitinib

Summary:

      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.
    

Eligibility criteria:

        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.