- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076504
A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer
April 1, 2016 updated by: SCRI Development Innovations, LLC
A Phase II Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer
This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC).
Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment cycle.
This trial will be the first clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line treatment of ES SCLC in a U.S. population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- Northeast Arkansas Clinic
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Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists
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Lakeland, Florida, United States, 33805
- Watson Clinic Center for Cancer Care and Research
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Orlando, Florida, United States, 32804
- Florida Hospital Cancer Institute
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Georgia
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Augusta, Georgia, United States, 30901
- Medical Oncology Associates of Augusta
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Kentucky
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Louisville, Kentucky, United States, 40207
- Norton Cancer Institute
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East
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Louisiana
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Baton Rouge, Louisiana, United States, 70806
- Hematology Oncology Clinic, LLP
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Maryland
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Bethesda, Maryland, United States, 20817
- Center For Cancer And Blood Disorders
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Bethesda, Maryland, United States, 20817
- National Capital Clinical Research Consortium
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Grand Rapids Clinical Oncology Program
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Missouri
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Kansas City, Missouri, United States, 64132
- Research Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care
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South Carolina
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Columbia, South Carolina, United States, 29210
- South Carolina Oncology Associates, PA
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology Hematology Associates
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Collierville, Tennessee, United States, 38017
- Family Cancer Center
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Nashville, Tennessee, United States, 37023
- Tennessee Oncology, PLLC
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Virginia
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Newport News, Virginia, United States, 23601
- Peninsula Cancer Institute
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Richmond, Virginia, United States, 23235
- Virginia Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cytologically and/or histologically confirmed small-cell lung cancer with extensive stage disease.
- Measurable or evaluable disease per RECIST criteria version 1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
- QTc interval of ≤450 msec. on ECG.
Adequate organ function, including the following:
- ANC ≥1500 cells/micro liter
- Platelet count ≥100,000 cells/micro liter
- Hemoglobin ≥9 g/dL
- Total bilirubin ≤1.5 x ULN; AST/ALT ≤2.5 x ULN, (except if due to hepatic metastases, then ≤5 x ULN)
- Serum creatinine ≤1.5 x ULN
- Patients must be able to receive growth factors (G-CSF).
- Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- Patients ≥18 years of age.
- Patients must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
- Previous treatment for limited-stage SCLC.
- Previous chemotherapy or radiation therapy for SCLC (unless radiation was administered for brain metastases).
- Active brain metastases. Patients with treated brain metastases are eligible, if (1) radiation therapy was completed ≥ 21 days prior to first dose of amrubicin; (2) follow-up scan shows no disease progression; an absence of neurologic symptoms and (3) patient does not require steroids.
- Mixed small cell/non-small cell tumors or other neuroendocrine lung cancers.
- Women who are pregnant or breastfeeding.
- Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.
- Patients with New York Heart Association (NYHA) class II or greater congestive heart failure (CHF).
Any of the following ≤6 months prior to starting study treatment:
- myocardial infarction;
- severe unstable angina;
- ongoing cardiac dysrhythmia.
- Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.
- Treatment for other invasive cancers during the previous 5 years, or the presence of any active invasive cancer of any type (with the exception of non-melanoma skin cancers).
- Uncontrolled hypertension (i.e., blood pressure >150/90 mmHg that cannot be controlled with standard anti-hypertensive agents).
- Major surgical procedure or significant traumatic injury ≤ 28 days of study initiation.
- History of seropositive HIV or patients who are receiving immunosuppressive medications that would in the opinion of the investigator increase the risk of the serious neutropenic complications.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Use of any non-approved or investigational agent ≤30 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Amrubicin/Carboplatin with Pegfilgrastim
Systemic therapy
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30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Other Names:
AUC=5 IV, Day 1 of each 3-week treatment cycle
Other Names:
6 mg SQ on Day 4 of each 3 week treatment cycle
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-year Survival
Time Frame: 12 months
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Percentage of patients still alive one year after their first treatment
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: 36 months
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The Percentage of Patients Who Experience an Objective Benefit From Treatment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
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36 months
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Time to Progression
Time Frame: 36 months
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Time to progression will be defined as the time from first treatment until objective tumor progression (PD).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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36 months
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Overall Survival
Time Frame: 84 months
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The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
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84 months
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Toxicity/Safety
Time Frame: 36 months
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Grade 3/4 toxicities
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36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: David R Spigel, M.D., SCRI Development Innovations, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
December 8, 2009
First Submitted That Met QC Criteria
February 24, 2010
First Posted (Estimate)
February 26, 2010
Study Record Updates
Last Update Posted (Estimate)
May 5, 2016
Last Update Submitted That Met QC Criteria
April 1, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCRI LUN 199
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Extensive-Stage Small Cell Lung Cancer
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Zhejiang Cancer HospitalRecruitingExtensive Stage Lung Small Cell CancerChina
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
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Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
-
National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
-
European Organisation for Research and Treatment...UNICANCERRecruitingExtensive-stage Small-cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited Kingdom, Belgium, Switzerland, Italy, France, Germany, Poland, Spain, Austria
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Intergroupe Francophone de Cancerologie ThoraciqueCompletedSmall Cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive StageFrance
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University of WashingtonAstraZenecaWithdrawnStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell CarcinomaUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell CarcinomaUnited States
-
National Cancer Institute (NCI)TerminatedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
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National Cancer Institute (NCI)CompletedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
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