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

NCT00695292 | Completed Phase 2 Results

• 1 other identifier: SCRI LUN 156
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 10

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.

Conditions

Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; Extensive Stage; irinotecan; carboplatin; sunitinib

Outcome Measures

Primary Outcomes (1)

• One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment

  18 months

Secondary Outcomes (4)

• Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

  18 months

• Time to Progression

  18 months

• Median Overall Survival

  18 months

• Number of Participants Experiencing Treatment Related Toxicity

  18 months

Study Arms (1)

Intervention

EXPERIMENTAL

Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs. Re-staging will be performed every 2 cycles (every 8 weeks) during the study.

Drug: irinotecan; Drug: Carboplatin; Drug: sunitinib

Interventions

irinotecan DRUG

irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15

Also known as: Camptosar

Intervention

Carboplatin DRUG

carboplatin AUC=4 on Day 1

Also known as: Paraplatin

Intervention

sunitinib DRUG

sunitinib 25 mg orally (PO) daily after initial chemotherapy

Also known as: Sutent

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Pfizer: collaborator

Study Sites (10)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Florida Hospital Cancer Insitute

Orlando, Florida, 32804, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70806, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

St. Louis Cancer Care

Chesterfield, Missouri, 63017, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Irinotecan; Carboplatin; Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. David Spigel
• Organization: Sarah Cannon Research Institute

askSARAH@scresearch.net

615-329-7274

Study Officials

• David R Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2012
• Last Updated: November 22, 2021
• Results First Posted: February 15, 2013

Record last verified: 2021-11

Locations

US (10)