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

Phase 2

Completed

• Conditions: Extensive-Stage Small Cell Lung Cancer
• Interventions: Drug: Amrubicin; Drug: Carboplatin; Drug: Pegfilgrastim

• Registration Number: NCT01076504
• Lead Sponsor: SCRI Development Innovations, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-26
• Primary Completion: 2012-03
• Study Completion: 2015-03
• Results First Submitted: 2015-04-30
• Results First Submitted QC: 2015-11-06
• Results First Posted: 2015-12-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amrubicin/Carboplatin with Pegfilgrastim	Amrubicin	Systemic therapy
Amrubicin/Carboplatin with Pegfilgrastim	Carboplatin	Systemic therapy
Amrubicin/Carboplatin with Pegfilgrastim	Pegfilgrastim	Systemic therapy

Primary Outcome Measures

Name	Time	Method
1-year Survival	12 months	Percentage of patients still alive one year after their first treatment

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	36 months	The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time to Progression	36 months	Time to progression will be defined as the time from first treatment until objective tumor progression (PD). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival	84 months	The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Toxicity/Safety	36 months	Grade 3/4 toxicities

Trial Locations

Locations (20)

Medical Oncology Associates of Augusta; 🇺🇸 Augusta, Georgia, United States

Northeast Arkansas Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Chattanooga Oncology Hematology Associates; 🇺🇸 Chattanooga, Tennessee, United States

Watson Clinic Center for Cancer Care and Research; 🇺🇸 Lakeland, Florida, United States

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Grand Rapids Clinical Oncology Program; 🇺🇸 Grand Rapids, Michigan, United States

Research Medical Center; 🇺🇸 Kansas City, Missouri, United States

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Florida Hospital Cancer Institute; 🇺🇸 Orlando, Florida, United States

National Capital Clinical Research Consortium; 🇺🇸 Bethesda, Maryland, 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

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

South Carolina Oncology Associates, PA; 🇺🇸 Columbia, South Carolina, United States

Family Cancer Center; 🇺🇸 Collierville, Tennessee, United States

Virginia Cancer Institute; 🇺🇸 Richmond, Virginia, United States

Peninsula Cancer Institute; 🇺🇸 Newport News, Virginia, United States

Nebraska Methodist Cancer Center; 🇺🇸 Omaha, Nebraska, United States