PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies

Georgetown University

Status and phase

Unknown

Phase 1

Conditions

Advanced Solid Tumor Malignancies

Treatments

Drug: PD-0332991

Drug: 5-FU

Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01522989

WS1877559 (Other Identifier)

2011-219

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 </= 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 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)