NCT00890955

Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Lawrence Einhorn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Amrubicin	* Dose Level -1: 20mg/m2 * Dose Level 1: 25mg/m2 * Dose Level 2: 30mg/m2 * Dose Level 3: 35mg/m2 * Dose Level 4: 40mg/m2 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.
DRUG	Cyclophosphamide	Cyclophosphamide will be given at a fixed dose as 500mg/m2 IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-04-30
• Last updated: 2015-12-23

Locations

10 sites across 1 country: United States