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A Phase I/II Study of Gleevec® Combined With Panitumumab (Vectibix®) in Patients Prescreened for C-kit/PDGFr Activated Pathways Using a Proteomic Based Assay

Phase 1/Phase 2
18 Years
Not Enrolling
Colorectal Neoplasm, Colorectal Cancer

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Trial Information

A Phase I/II Study of Gleevec® Combined With Panitumumab (Vectibix®) in Patients Prescreened for C-kit/PDGFr Activated Pathways Using a Proteomic Based Assay

Inclusion Criteria:

- Patients ≥ 18 years of age.

- Histologically documented diagnosis of Stage IV Metastatic Colorectal Cancer with
Liver Metastases, refractory or progressive after at least one (1) prior line of
therapy that must include a fluoropyrimidine (5-fluorouracil or capecitabine) AND
(oxaliplatin OR irinotecan), i.e. FOLFOX, FOLFIRI, XELOX, or XELIRI.

- Documentation of wild type k-Ras expression in the liver lesion.

- At least one measurable site of disease (as defined by Response Evaluation Criteria
in Solid Tumors, see Appendix 3), or other response assessment criteria, as

- Must have ≥ 1 measurable liver lesion that can be accessed by CT guided biopsy.

- Performance status 0,1, or 2 (ECOG).

- Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN,
SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 1.5 x 10^9/L, platelets >
100 x 10^9/L.

- Life expectancy of at least 3 months.

- Female patients of childbearing potential must have negative pregnancy test within 7
days before initiation of study drug dosing. Postmenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential. Female
patients of reproductive potential must agree to employ an effective barrier method
of birth control throughout the study and for up to 7 days following discontinuation
of study drug.

- Written, voluntary informed consent.

Exclusion Criteria:

- Patient has received any other investigational agents within 28 days of first day of
study drug dosing, unless the disease is rapidly progressing.

- Patient is < 5 years free of another primary malignancy except: if the other primary
malignancy is neither currently clinically significant nor requiring active
intervention, or if other primary malignancy is a basal cell skin cancer or a
cervical carcinoma in situ. Existence of any other malignant disease is not allowed.

- Patient with Grade III/IV cardiac problems as defined by the New York Heart
Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6
months of study)

- Female patients who are pregnant or breast-feeding.

- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled
diabetes, chronic renal disease, or active uncontrolled infection).

- Patient has a known brain metastasis not treated with definitive therapy with stable
disease ≥ 4 weeks.

- Patient has known chronic liver disease (i.e., chronic active hepatitis, and

- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

- Patient received chemotherapy within 2 weeks (6 weeks for nitrosourea or
mitomycin-C)prior to study entry, unless the disease is rapidly progressing.

- Patient previously received radiotherapy to ≥ 25% of the bone marrow

- Patient had a major surgery within 2 weeks prior to study entry.

- Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent.

- Patients intolerant to imatinib mesylate.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety and tolerability of the combination imatinib mesylate and panitumumab in this population.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Kirsten Edmiston, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Inova Fairfax Hospital Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

August 2011

Related Keywords:

  • Colorectal Neoplasm
  • Colorectal Cancer
  • colorectal neoplasm
  • colorectal cancer
  • imatinib mesylate
  • Gleevec
  • Physiological Effects of Drugs
  • panitumumab
  • Vectibix
  • c-kit receptor
  • Receptor
  • Platelet-Derived Growth Factor alpha
  • Neoplasms
  • Colorectal Neoplasms



Virginia Cancer Specialists, PC Fairfax, Virginia  22031
Inova Fairfax Hospital Cancer Center Falls Church, Virginia  22042