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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01076504
First received: December 8, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Extensive-Stage Small Cell Lung Cancer
Drug: Amrubicin
Drug: Carboplatin
Drug: Pegfilgrastim
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • To assess the 1-year survival of patients with ES-SCLC when receiving amrubicin and carboplatin in combination. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 84 months ] [ Designated as safety issue: No ]
  • Toxicity/Safety [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amrubicin/Carboplatin with Pegfilgrastim
Systemic therapy
Drug: Amrubicin
30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Other Name: SM-5887
Drug: Carboplatin
AUC=5 IV, Day 1 of each 3-week treatment cycle
Other Names:
  • cis-Diammine
  • Paraplatin
  • Paraplatin-AQ
Drug: Pegfilgrastim
6 mg SQ on Day 4 of each 3 week treatment cycle
Other Name: Neulasta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076504

Locations
United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30901
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Louisiana
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, United States, 70806
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, United States, 20817
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, Nebraska
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Family Cancer Center
Collierville, Tennessee, United States, 38017
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Virginia Cancer Institute
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
SCRI Development Innovations, LLC
Celgene Corporation
Investigators
Study Chair: David R Spigel, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01076504     History of Changes
Other Study ID Numbers: SCRI LUN 199
Study First Received: December 8, 2009
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
SCLC
Amrubicin
Carboplatin
Pegfilgrastim
Neulasta

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Amrubicin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014