New Individualized Therapy Trial for Metastatic Colorectal Cancer (NITMEC)

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT00867334
First received: March 19, 2009
Last updated: March 11, 2014
Last verified: March 2014
  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 Intervention Phase
Colorectal Neoplasm
Colorectal Cancer
Drug: Imatinib mesylate followed by a combination of imatinib mesylate & panitumumab
Drug: Standard-of-care treatment with panitumumab
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

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 ]

Enrollment: 10
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
Drug: Imatinib mesylate followed by a combination of imatinib mesylate & panitumumab
Patients will be entered into sequential cohorts with escalating doses of imatinib mesylate. After approximately 28 days of monotherapy treatment with imatinib mesylate, patients will be asked to have a liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study). All patients in this group will then receive imatinib mesylate in combination with standard-of-care doses of panitumumab. After approximately 1-2 months of combination treatment, patients will asked to have an additional liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study). Combination treatment will continue for the remainder of the subject's time in the trial.
Other Names:
  • Gleevec
  • ST1571
Active Comparator: 2
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 2. Participants in Arm 2 will receive standard-of-care treatment with panitumumab.
Drug: Standard-of-care treatment with panitumumab
Panitumumab as standard of care. After approximately 2-3 months of standard of care treatment, patients will asked to have a liver biopsy performed (this biopsy is voluntary and is not required for continued participation in the study).
Other Names:
  • Vectibix
  • ABX-EGF monoclonal antibody

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867334

Locations
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Inova Fairfax Hospital Department of Surgery
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Novartis Pharmaceuticals
Investigators
Principal Investigator: Kirsten Edmiston, MD, FACS Inova Fairfax Hospital Cancer Center
  More Information

No publications provided

Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT00867334     History of Changes
Other Study ID Numbers: CSTI571BUS278T
Study First Received: March 19, 2009
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Inova Health Care Services:
colorectal neoplasm
colorectal cancer
imatinib mesylate
Gleevec
Physiological Effects of Drugs
panitumumab
Vectibix
c-kit receptor
Receptor
Platelet-Derived Growth Factor alpha

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Imatinib
Physiological Effects of Drugs
Immunologic Factors
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014