Clinical trial NCT00695292: Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
Official title: Phase II Study of Irinotecan, Carboplatin, and Sunitinib in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
Extensive Stage
irinotecan
carboplatin
sunitinib
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-06-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 previous Phase II SCLC trials, and were found to be extremely well tolerated (Thompson et al. 2005; Spigel et al. 2007). Adding a novel, minimally toxic agent to this regimen may further enhance efficacy in this patient population without contributing to toxicity. This trial will evaluate the use of sunitinib following 6 cycles of treatment with chemotherapy in the treatment of SCLC.

The trial will be performed under the leadership of SCRI, a community-based, multi-center, clinical trial organization.

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.

Primary outcomes:
measure: One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment
timeFrame: 18 months
Secondary outcomes:
measure: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
timeFrame: 18 months
measure: Time to Progression
timeFrame: 18 months
measure: Median Overall Survival
timeFrame: 18 months
measure: Number of Participants Experiencing Treatment Related Toxicity
timeFrame: 18 months
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Insitute
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Chesterfield
country: United States
facility: St. Louis Cancer Care
state: Missouri
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R Spigel, M.D.
role: STUDY_CHAIR
References: