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

NCT01076504 | Completed Phase 2 Results

• 1 other identifier: SCRI LUN 199
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Extensive-Stage Small Cell Lung Cancer

Keywords

SCLC; Amrubicin; Carboplatin; Pegfilgrastim; Neulasta

Outcome Measures

Primary Outcomes (1)

• 1-year Survival

  Percentage of patients still alive one year after their first treatment

  12 months

Secondary Outcomes (4)

• Objective Response Rate

  36 months

• Time to Progression

  36 months

• Overall Survival

  84 months

• Toxicity/Safety

  36 months

Study Arms (1)

Amrubicin/Carboplatin with Pegfilgrastim

EXPERIMENTAL

Systemic therapy

Drug: Amrubicin; Drug: Carboplatin; Drug: Pegfilgrastim

Interventions

Amrubicin DRUG

30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle

Also known as: SM-5887

Amrubicin/Carboplatin with Pegfilgrastim

Carboplatin DRUG

AUC=5 IV, Day 1 of each 3-week treatment cycle

Also known as: cis-Diammine, Paraplatin, Paraplatin-AQ

Amrubicin/Carboplatin with Pegfilgrastim

Pegfilgrastim DRUG

6 mg SQ on Day 4 of each 3 week treatment cycle

Also known as: Neulasta

Amrubicin/Carboplatin with Pegfilgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Celgene: collaborator

Study Sites (20)

Northeast Arkansas Clinic

Jonesboro, Arkansas, 72401, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Medical Oncology Associates of Augusta

Augusta, Georgia, 30901, United States

Location

Baptist Hospital East

Louisville, Kentucky, 40207, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Hematology Oncology Clinic, LLP

Baton Rouge, Louisiana, 70806, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

National Capital Clinical Research Consortium

Bethesda, Maryland, 20817, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Nebraska Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

South Carolina Oncology Associates, PA

Columbia, South Carolina, 29210, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

amrubicin; Carboplatin; pegfilgrastim

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: John D Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• David R Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: February 26, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2015
• Last Updated: May 5, 2016
• Results First Posted: December 10, 2015

Record last verified: 2016-04

Locations

US (20)