Status:
UNKNOWN
PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Pfizer
Conditions:
Advanced Solid Tumor Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combi...
Eligibility Criteria
Inclusion
- Retinoblastoma-positive, histologically proven advanced solid tumor malignancies for which no curative therapy exists
- Biopsy accessible tumor deposits
- Corrected QT interval less than 500 milliseconds by EKG
- ECOG preformance status 0-2
- Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment.
- Adequate hepatic, bone marrow, and renal function
- Partial thromboplastin time must be \</= 1.5 x upper limit normal range and INR \< 1.5. Subjects on anticoagulant will be permitted to enroll as long as the INR is in acceptable therapeutic range.
- Life expectancy \> 12 weeks
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months.
- Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent.
Exclusion
- Intolerant of, or ineligible for 5-FU, oxaliplatin and/or the combination of both
- CNS metastases that do not meet the criteria outlined in the inclusion criteria
- Peripheral neuropathy \>/= Grade 2 at baseline or peripheral neuropathy \>/= Grade 1 with neuropathic pain
- Active severe infection or known chronic infection with HIV or hepatitis B virus
- Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia or myocardial infarction, stroke, or congestive heart failure within the last 6 months.
- Life-threatening visceral disease or other severe concurrent disease
- Women who are pregnant or breastfeeding
- Anticipated patient survival under 3 months
- Concurrent use of known CYP 3A4 inhibiting or activating medications
- Clinically significant and uncontrolled major medical condition(s)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01522989
Start Date
December 1 2011
End Date
December 1 2020
Last Update
March 4 2020
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007