Status:
COMPLETED
Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies
Lead Sponsor:
Lawrence Einhorn
Collaborating Sponsors:
Celgene Corporation
Hoosier Cancer Research Network
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 safel...
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 2...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced solid organ malignancy that is refractory to currently available therapies or for which no effective therapy exists.
- 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
- No prior therapy with cyclophosphamide or anthracyclines.
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00890955
Start Date
March 1 2009
End Date
July 1 2010
Last Update
December 23 2015
Active Locations (10)
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1
Highlands Oncology Group
Springdale, Arkansas, United States, 72764
2
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
3
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
4
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403