Know Cancer

forgot password

A Phase I Study of the CDK4/6 Inhibitor PD-0332991, 5-Fluorouracil, and Oxaliplatin in Patients With Advanced Refractory Colorectal Cancer

Phase 1
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

A Phase I Study of the CDK4/6 Inhibitor PD-0332991, 5-Fluorouracil, and Oxaliplatin in Patients With Advanced Refractory Colorectal Cancer

Inclusion Criteria:

- Retinoblastoma-positive, histologically proven colorectal cancer with measurable

- Progression on, or intolerance of, or ineligibility for all standard therapies
(including regimens containing fluoropyrimidine, oxaliplatin, irinotecan,
bevacizumab, and an anti-EGFR antibody (where appropriate).

- 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended Phase 2 dose and schedule

Outcome Description:

The dose and schedule of PD-0332991 to be used in combination with 5-FU

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Michael Pishvaian, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer
  • Advanced
  • Refractory
  • Colorectal Neoplasms



Georgetown Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007