Status:
COMPLETED
Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Pfizer
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 previ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00695292
Start Date
June 1 2008
End Date
September 1 2012
Last Update
November 22 2021
Active Locations (10)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Florida Hospital Cancer Insitute
Orlando, Florida, United States, 32804
3
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
4
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806