CompletedPhase 2NCT00695292
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedirinotecan and Carboplatin

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 22, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?SCRI Development Innovations, LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
SCRI Development Innovations, LLC
Interventions being studied
Drug: irinotecan; Drug: Carboplatin; Drug: sunitinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Cancer SpecialistsFort Myers, Florida
  • Florida Hospital Cancer InsituteOrlando, Florida
  • Northeast Georgia Medical CenterGainesville, Georgia
  • Baton Rouge General Medical CenterBaton Rouge, Louisiana
  • Center for Cancer and Blood DisordersBethesda, Maryland
  • St. Louis Cancer CareChesterfield, Missouri
  • Oncology Hematology CareCincinnati, Ohio
  • Spartanburg Regional Medical CenterSpartanburg, South Carolina
  • Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee
  • Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 22, 2021. Always confirm current availability with the study team.

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