PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/6/2018 |
| Start Date: | December 2011 |
| End Date: | September 2019 |
A Phase I Study of the CDK4/6 Inhibitor PD-0332991, 5-Fluorouracil, and Oxaliplatin in Patients With Advanced Solid Tumor Malignancies
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 combination of
drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor
malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called
cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this
enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil
and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus
decreasing the tumors in the body.
PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been
approved by the Food and Drug Administration for use in colorectal cancer. It is given as a
pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and
Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved
for and used as chemotherapy for several cancers.
other parts of the body).
The purpose of this study is to test the safety and effectiveness of a new combination of
drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor
malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called
cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this
enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil
and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus
decreasing the tumors in the body.
PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been
approved by the Food and Drug Administration for use in colorectal cancer. It is given as a
pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and
Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved
for and used as chemotherapy for several cancers.
Inclusion Criteria:
- 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 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 Criteria:
- 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)
We found this trial at
1
site
Washington, District of Columbia 20007
Principal Investigator: Michael Pishvaian, MD PhD
Phone: 202-687-2111
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