A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Extensive-Stage Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01076504

Run by

SCRI Development Innovations, LLC

People needed

81

Starts

2009-12-01

Expected to finish

2015-03-01

Last updated by the study team

2016-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Watson Clinic Center for Cancer Care and Research — Lakeland, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Medical Oncology Associates of Augusta — Augusta, Georgia, United States
• Baptist Hospital East — Louisville, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Hematology Oncology Clinic, LLP — Baton Rouge, Louisiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• National Capital Clinical Research Consortium — Bethesda, Maryland, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• Research Medical Center — Kansas City, Missouri, United States
• Nebraska Methodist Cancer Center — Omaha, Nebraska, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• South Carolina Oncology Associates, PA — Columbia, South Carolina, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Family Cancer Center — Collierville, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Peninsula Cancer Institute — Newport News, Virginia, United States
• Virginia Cancer Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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