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

NCT00695292

Last updated date
Study Location
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Small Cell Lung CancerA Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
NCT00168896
  1. Berlin,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Small Cell Lung CancerIrinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
NCT00695292
  1. Fort Myers, Florida
  2. Orlando, Florida
  3. Gainesville, Georgia
  4. Baton Rouge, Louisiana
  5. Bethesda, Maryland
  6. Chesterfield, Missouri
  7. Cincinnati, Ohio
  8. Spartanburg, South Carolina
  9. Chattanooga, Tennessee
  10. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
Official Title  ICMJE Phase II Study of Irinotecan, Carboplatin, and Sunitinib in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: irinotecan
    irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15
    Other Name: Camptosar
  • Drug: Carboplatin
    carboplatin AUC=4 on Day 1
    Other Name: Paraplatin
  • Drug: sunitinib
    sunitinib 25 mg orally (PO) daily after initial chemotherapy
    Other Name: Sutent
Study Arms  ICMJE Experimental: Intervention

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.

Interventions:
  • Drug: irinotecan
  • Drug: Carboplatin
  • Drug: sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2013)
37
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2008)
38
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00695292
Other Study ID Numbers  ICMJE SCRI LUN 156
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SCRI Development Innovations, LLC
Study Sponsor  ICMJE SCRI Development Innovations, LLC
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:David R Spigel, M.D.SCRI Development Innovations, LLC
PRS Account SCRI Development Innovations, LLC
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP