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New Individualized Therapy Trial for Metastatic Colorectal Cancer

Information source: Inova Health Care Services
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Neoplasm; Colorectal Cancer

Intervention: Imatinib mesylate followed by a combination of imatinib mesylate & panitumumab (Drug); Standard-of-care treatment with panitumumab (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Inova Health Care Services

Official(s) and/or principal investigator(s):
Kirsten Edmiston, MD, FACS, Principal Investigator, Affiliation: Inova Fairfax Hospital Cancer Center

Summary

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.

Clinical Details

Official title: 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

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

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

Secondary outcome: Stabilization or reduction in tumor size by imaging of the hepatic metastasis.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Virginia Cancer Specialists, PC, Fairfax, Virginia 22031, United States

Inova Fairfax Hospital Department of Surgery, Falls Church, Virginia 22042, United States

Additional Information

Starting date: June 2009
Last updated: March 11, 2014

Page last updated: August 23, 2015

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