Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies
NCT ID: NCT00890955
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2009-03-31
2010-07-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Amrubicin + Cyclophosphamide 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
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* Must have measurable or evaluable disease per RECIST as evaluated by imaging within 30 days prior to registration for protocol therapy.
* Must have completed chemotherapy at least 28 days prior to registration for protocol therapy and recovered from the acute toxic effects.
* Prior radiation therapy is allowed to \< 25% of the bone marrow. Patients must have recovered from the acute toxic effects of radiation prior to registration for protocol therapy.
* Must be willing to consent to the blood sample collection for SNP analysis.
* Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 30 days following completion of protocol therapy.
* Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
* Written informed consent and HIPAA authorization for release of personal health information.
* Age \> 18 years.
Exclusion Criteria
* No treatment with any investigational agent within 28 days prior to registration for protocol therapy.
* No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.
* No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
* No symptomatic brain metastases. Patients with treated brain metastasis must be off steroids and must have completed radiation at least 21 days prior to registration for protocol therapy.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Hoosier Cancer Research Network
OTHER
Lawrence Einhorn
OTHER
Responsible Party
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Lawrence Einhorn
Sponsor-Investigator
Principal Investigators
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Lawrence Einhorn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hoosier Cancer Research Network
Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
Helen F. Graham Cancer Center
Newark, Delaware, United States
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Medical Consultants, P.C.
Muncie, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Siteman Cancer Center
St Louis, Missouri, United States
Providence Portland Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center Extramural Research Program
Rockledge, Pennsylvania, United States
Countries
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References
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Jalal SI, Hanna N, Zon R, Masters GA, Borghaei H, Koneru K, Badve S, Prasad N, Somaiah N, Wu J, Yu Z, Einhorn L. Phase I Study of Amrubicin and Cyclophosphamide in Patients With Advanced Solid Organ Malignancies: HOG LUN 07-130. Am J Clin Oncol. 2017 Aug;40(4):329-335. doi: 10.1097/COC.0000000000000160.
Related Links
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Hoosier Oncology Group Homepage
Other Identifiers
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HOG LUN07-130
Identifier Type: -
Identifier Source: org_study_id