Phase 2
N=37
Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00695292 ↗Enrolled (actual)
37
Serious AEs
48.7%
Results posted
Feb 2013
Primary outcome: Primary: One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment — 54 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- irinotecan (Drug); Carboplatin (Drug); sunitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment |
54 | — |
| SECONDARY Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
59 | — |
| SECONDARY Time to Progression |
7.6 | — |
| SECONDARY Median Overall Survival |
NA | — |
| SECONDARY Number of Participants Experiencing Treatment Related Toxicity |
32 | — |
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
- 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) =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
- 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.
Data sourced from ClinicalTrials.gov (NCT00695292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.