This study is currently recruiting participants.
Verified by Inova Health Care Services, June 2009
First Received: March 19, 2009  
Last Updated: June 10, 2009  
History of Changes

Sponsors and Collaborators:
Inova Health Care Services/Novartis Pharmaceuticals

Purpose:
The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in combination with panitumumab for the treatment of stage IV colorectal cancer that has spread to the liver. It will also assess the whether imatinib mesylate, either alone or in combination with panitumumab, is effective in treating this type of cancer. In addition, the study will evaluate the feasibility of a predefined lab score and whether it can predict which patients will respond to treatment with imatinib mesylate.

Condition: Colorectal Neoplasm, Colorectal Cancer

Intervention: Phase I Drug: Imatinib mesylate followed by a combination of imatinib mesylate & panitumumab; Phase II Drug: Standard-of-care treatment with panitumumab

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Further study details:

Primary Outcome Measures:

• Assess the safety and tolerability of the combination imatinib mesylate and panitumumab in this population.
  [ Time Frame: Continually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• Stabilization or reduction in tumor size by imaging of the hepatic metastasis.
  [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:  18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

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 appropriate.
• 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 cirrhosis).
• 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.

Contacts and Locations

Contacts

Locations

United States, Virginia
Fairfax Northern Virginia Hematology Oncololgy PC Fairfax, Virginia, United States, 22031 Contact: Stacey Banks     703-776-3565     stacey.banks@inova.org     Alex Spira, MD, PhD     703.280.5390     alexander.spira@usoncology.com     Sub-Investigator: Alex Spira, MD, PhD	Recruiting
Inova Fairfax Hospital Cancer Center Falls Church, Virginia, United States, 22042 Contact: Stacey Banks     703-776-3565     stacey.banks@inova.org   Kirsten Edmiston, MD, FACS     703.776.8675     kirsten.edmiston@inova.org   Principal Investigator: Kirsten Edmiston, MD, FACS	Recruiting

Investigators