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

Information source: SCRI Development Innovations, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Extensive-Stage Small Cell Lung Cancer

Intervention: Amrubicin (Drug); Carboplatin (Drug); Pegfilgrastim (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: SCRI Development Innovations, LLC

Official(s) and/or principal investigator(s):
David R Spigel, M.D., Study Chair, Affiliation: SCRI Development Innovations, LLC

Summary

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.

Clinical Details

Official title: A Phase II Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess the 1-year survival of patients with ES-SCLC when receiving amrubicin and carboplatin in combination.

Secondary outcome:

Objective response rate

Time to progression

Overall survival

Toxicity/Safety

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Cytologically and/or histologically confirmed small-cell lung cancer with extensive stage disease. 2. Measurable or evaluable disease per RECIST criteria version 1. 1. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. 4. Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA). 5. QTc interval of ≤450 msec. on ECG. 6. 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

7. Patients must be able to receive growth factors (G-CSF). 8. 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. 9. Patients ≥18 years of age. 10. Patients must be accessible for treatment and follow-up. 11. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry. Exclusion Criteria: 1. Previous treatment for limited-stage SCLC. 2. Previous chemotherapy or radiation therapy for SCLC (unless radiation was administered for brain metastases). 3. 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. 4. Mixed small cell/non-small cell tumors or other neuroendocrine lung cancers. 5. Women who are pregnant or breastfeeding. 6. Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis. 7. Patients with New York Heart Association (NYHA) class II or greater congestive heart failure (CHF). 8. Any of the following ≤6 months prior to starting study treatment:

- myocardial infarction;

- severe unstable angina;

- ongoing cardiac dysrhythmia.

9. Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia. 10. 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). 11. Uncontrolled hypertension (i. e., blood pressure >150/90 mmHg that cannot be controlled with standard anti-hypertensive agents). 12. Major surgical procedure or significant traumatic injury ≤ 28 days of study initiation. 13. 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. 14. 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. 15. Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study. 16. 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.

Locations and Contacts

Northeast Arkansas Clinic, Jonesboro, Arkansas 72401, United States

Florida Cancer Specialists, Fort Myers, Florida 33901, United States

Watson Clinic Center for Cancer Care and Research, Lakeland, Florida 33805, United States

Florida Hospital Cancer Institute, Orlando, Florida 32804, United States

Medical Oncology Associates of Augusta, Augusta, Georgia 30901, United States

Baptist Hospital East, Louisville, Kentucky 40207, United States

Norton Cancer Institute, Louisville, Kentucky 40207, United States

Hematology Oncology Clinic, LLP, Baton Rouge, Louisiana 70806, United States

Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States

National Capital Clinical Research Consortium, Bethesda, Maryland 20817, United States

Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

Research Medical Center, Kansas City, Missouri 64132, United States

Nebraska Methodist Cancer Center, Omaha, Nebraska 68114, United States

Oncology Hematology Care, Cincinnati, Ohio 45242, United States

South Carolina Oncology Associates, PA, Columbia, South Carolina 29210, United States

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee 37404, United States

Family Cancer Center, Collierville, Tennessee 38017, United States

Tennessee Oncology, PLLC, Nashville, Tennessee 37023, United States

Peninsula Cancer Institute, Newport News, Virginia 23601, United States

Virginia Cancer Institute, Richmond, Virginia 23235, United States

Additional Information

Starting date: December 2009
Last updated: March 18, 2015

Page last updated: August 23, 2015

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