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

Extensive-Stage Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076504
• Other study ID #: SCRI LUN 199
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2009
• Last updated: November 6, 2015
• Start date: December 2009
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Extensive-Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Amrubicin
30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
• Carboplatin
AUC=5 IV, Day 1 of each 3-week treatment cycle
• Pegfilgrastim
6 mg SQ on Day 4 of each 3 week treatment cycle

Locations

Country	Name	City	State
United States	Medical Oncology Associates of Augusta	Augusta	Georgia
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	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Family Cancer Center	Collierville	Tennessee
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	Northeast Arkansas Clinic	Jonesboro	Arkansas
United States	Research Medical Center	Kansas City	Missouri
United States	Watson Clinic Center for Cancer Care and Research	Lakeland	Florida
United States	Baptist Hospital East	Louisville	Kentucky
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Nebraska Methodist Cancer Center	Omaha	Nebraska
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Virginia Cancer Institute	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year Survival	Percentage of patients still alive one year after their first treatment	12 months	No
Secondary	Objective Response Rate	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.	36 months	No
Secondary	Time to Progression	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.	36 months	No
Secondary	Overall Survival	The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	84 months	No
Secondary	Toxicity/Safety	Grade 3/4 toxicities	36 months	Yes