Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies

Lung Cancer Clinical Trial

Official title: A Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies

Status Completed

Clinical Trial Summary

Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful.

This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.

Clinical Trial Description

OUTLINE: This is a multi-center study.

This study will follow the 3+3 design with the following dose levels:

• Dose Level -1: Amrubicin 20mg/m2, Cyclophosphamide 500mg/m2

• Dose Level 1: Amrubicin 25mg/m2, Cyclophosphamide 500mg/m2

• Dose Level 2: Amrubicin 30mg/m2, Cyclophosphamide 500mg/m2

• Dose Level 3: Amrubicin 35mg/m2, Cyclophosphamide 500mg/m2

• Dose Level 4: Amrubicin 40mg/m2, Cyclophosphamide 500mg/m2

Dose escalation starts from dose level 1.

Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle.

Cyclophosphamide will be given at a fixed dose as an IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).

ECOG Performance Status: 0-1

Life expectancy: not specified

Hematopoietic:

• Hemoglobin (Hgb) > 9 g/dL.

• Platelets > 100 K/mm3

• Absolute Neutrophil Count (ANC) > 1.5 K/mm3

Hepatic:

• Aspartate transaminase (AST) ≤ 2.5 x ULN

• Alanine transaminase (ALT) ≤ 2.5 x ULN

• Total bilirubin < 1.5 x ULN

Renal:

• Calculated creatinine clearance ≥ 60cc/min

Cardiovascular:

• Left Ventricular Ejection Fraction (LVEF) ≥ LLN for institution within 60 days prior to registration for protocol therapy.

• No history of cardiomyopathy or uncontrolled heart arrhythmia.

Pulmonary:

• No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis. ;

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer

• NCT number: NCT00890955
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Completed
• Phase: Phase 1
• Start date: March 2009
• Completion date: July 2010