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A Phase I/II Clinical Trial of the Anti-EGFR Monoclonal Antibody, Panitumumab, and the Proteosomal Inhibitor, Bortezomib, in Patients With Advanced, Refractory KRAS Wild-Type Colorectal Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Phase I/II Clinical Trial of the Anti-EGFR Monoclonal Antibody, Panitumumab, and the Proteosomal Inhibitor, Bortezomib, in Patients With Advanced, Refractory KRAS Wild-Type Colorectal Cancer


Inclusion Criteria:



- Histologically proven colorectal cancer with measurable or evaluable disease

- KRAS wild-type colorectal cancer

- Progression on, or intolerance of, or ineligibility for all standard therapies

- Progression on prior anti-EGFR therapy

- Lesion that is amenable to biopsy

- ECOG performance status 0-2

- LVEF >/= institutional normal

- Corrected QT interval less then 500 milliseconds by EKG

- Grade 2 or less peripheral neuropathy

- Adequate hepatic, bone marrow, and renal function

- Partial thromboplastin time must be range and INR < 1.5. Subjects on anticoagulants will be permitted to enroll as long
as the INR is in the acceptable therapeutic range as determined by the investigator.

- 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.

- Life expectancy > 12 weeks

- Subject is capable of understanding and complying with parameters of the protocol and
able to sign and date the informed consent form.

Exclusion Criteria:

- CNS metastases which do not meet the criteria above

- Prior cancer chemotherapy, radiation therapy, or any investigational agent within
three weeks before starting therapy

- 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

- Peripheral neuropathy >/= Grade 2 at baseline or peripheral neuropathy >/= Grade 1
with neuropathic pain

- Life-threatening visceral disease or other severe concurrent disease

- Female subject is pregnant or lactating

- Diagnosed or treated for another malignancy within 3 years of enrollment with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, an in situ malignancy, or low risk prostate cancer after curative therapy

- Patient has hypersensitivity to bortezomib, boron, or mannitol

- Clinically significant and uncontrolled major medical condition(s)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose

Outcome Description:

The maximum tolerated dose of bortezomib to be used in combination with panitumumab

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Michael Pishvaian, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Food and Drug Administration

Study ID:

2011-033

NCT ID:

NCT01504477

Start Date:

December 2011

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • relapsed
  • refractory
  • Kras wild type
  • Colorectal Neoplasms

Name

Location

Georgetown Lombardi Comprehensive Cancer CenterWashington, District of Columbia  20007