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

NCT ID: NCT01076504

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2015-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amrubicin/Carboplatin with Pegfilgrastim

Systemic therapy

Group Type: EXPERIMENTAL

Amrubicin

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Pegfilgrastim

Intervention Type: DRUG

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

Interventions

Amrubicin

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Pegfilgrastim

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

Intervention Type: DRUG

Other Intervention Names

SM-5887; cis-Diammine; Paraplatin; Paraplatin-AQ; Neulasta

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Spigel, M.D.

Role: STUDY_CHAIR

SCRI Development Innovations, LLC

Locations

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

Countries

United States

Other Identifiers

SCRI LUN 199

Identifier Type: -

Identifier Source: org_study_id