Small Cell Lung CancerPhase 2NCT00695292
Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing irinotecan, Carboplatin and sunitinib in people with Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- irinotecan, Carboplatin and sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2008to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
St. Louis Cancer Care
Chesterfield, Missouri, 63017
Oncology Hematology Care
Cincinnati, Ohio, 45242
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Tennessee Oncology
Nashville, Tennessee, 37203
Florida Hospital Cancer Insitute
Orlando, Florida, 32804
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: Phase II Study of Irinotecan, Carboplatin, and Sunitinib in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer
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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- irinotecan, Carboplatin, sunitinib
- Keywords
- Small Cell Lung Cancer, Extensive Stage, irinotecan, carboplatin, sunitinib
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecanDrug
Also called Camptosar
irinotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15
CarboplatinDrug
Also called Paraplatin
carboplatin AUC=4 on Day 1
sunitinibDrug
Also called Sutent
sunitinib 25 mg orally (PO) daily after initial chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: irinotecan; Drug: Carboplatin; Drug: sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment
Measured: 18 months
Secondary outcomes (4)
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.
Measured: 18 months
Time to Progression
Time To Progression (TTP) was defined as the interval between the start date of treatment and the date of occurrence of progressive disease
Measured: 18 months
Median Overall Survival
Overall survival was defined as the interval between the date of study entry until the date of death.
Measured: 18 months
Number of Participants Experiencing Treatment Related Toxicity
The toxicity assessments were made according to the common terminology criteria for adverse events (CTCAE version 3.0) of the National Cancer Institute. Number of participants with Grade 1 to 5 adverse events are reported here.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- David R Spigel, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695292
- Sponsor's protocol ID
- SCRI LUN 156
- Status last verified
- Nov 2021
- First submitted
- 9 Jun 2008
- Last updated
- 22 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan, Carboplatin, and Sunitinib in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00695292
- Acronym / sponsor ID
- SCRI LUN 156
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer, Extensive Stage, irinotecan, carboplatin, sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Posted 15 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: irinotecan, Drug: Carboplatin, Drug: sunitinibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irinotecanAlso: Camptosaririnotecan 60 mg/m2 intravenously (IV) on Days 1, 8, and 15 | Drug | Intervention |
| CarboplatinAlso: Paraplatincarboplatin AUC=4 on Day 1 | Drug | Intervention |
| sunitinibAlso: Sutentsunitinib 25 mg orally (PO) daily after initial chemotherapy | Drug | Intervention |
Primary outcome
One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment
Time frame: 18 months
4 secondary outcomes
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Time frame: 18 months
Time to Progression
Time frame: 18 months
Median Overall Survival
Time frame: 18 months
Number of Participants Experiencing Treatment Related Toxicity
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Spigel, M.D. study chair
SCRI Development Innovations, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan, Carboplatin and sunitinib in people with Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.