Colon Cancer Clinical Trial
A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI
Summary
The purpose of this study is to test the safety of GI-4000 and see what effects (good and bad) it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to a standard of care which is a standard therapy given to patients with your type of cancer (colon).
Full Description
Subject visits will occur 1-4 weeks prior to initiation of GI-4000, then
In newly diagnosed (Group A) patients, at every FOLFOX/FOLFIRI plus bevacizumab visit, bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy
In patients with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen (Group B), at every bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy
Group A patients (N=26) will be enrolled into the study prior to the initiation of first line therapy with bevacizumab plus either FOLFOX (N=13) or FOLFIRI (N=13)
Subjects will receive 1 40 yeast units (YU) dose of GI-4000 prior to initiation of FOLFOX or FOLFIRI plus bevacizumab, then intercycle doses of GI-4000 will be given 7 days after each cycle while first line therapy is given (up to 8 cycles)
After completion of first line therapy, subjects will enter the maintenance phase in which bevacizumab and GI-4000 will be given concurrently every 2 weeks for as long as therapy can be tolerated or until progression
If a subject discontinues bevacizumab therapy due to intolerance, the subject will continue GI-4000 every 2 weeks until progression, intolerance or withdrawal from the study
Group B patients (N=26) with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen ) will enter the trial prior to receiving therapy with bevacizumab
Subjects will receive 40 yeast unit (YU) GI-4000 concurrently with each bevacizumab dose for as long as therapy can be tolerated or until progression
If a subject discontinues bevacizumab therapy due to intolerance, the subject will continue GI-4000 every 2 weeks until progression, intolerance or withdrawal from the study
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of metastatic colorectal cancer with a Ras mutation
Measurable or evaluable disease
No prior therapy fore metastatic disease except for group A: > 6 months since completion of adjuvant therapy and Group B: those patients who enroll just after completing bevacizumab plus FOLFOX or FOLFIRI
Anticipated survival of at least 6 months
Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Ability to maintain weight
Normal organ and marrow function
Women of child-bearing potential and men must agree to avoid pregnancy or fathering a child for the duration of study participation and for 6 months after the final scheduled study visit.
Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
Prior chemotherapy other than that listed in inclusion criteria
Receiving any other investigational agent
Known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
History of known hypersensitivity to S. cerevisiae, bevacizumab or any component of FOLFOX or FOLFIRI
Concurrent and chronic therapy with corticosteroids or any other immunosuppressive drugs
Uncontrolled hypertension, unstable angina, congestive heart failure, peripheral vascular disease, serious cardiac arrythmias requiring medication
History of heart attack or stroke within 6 months before enrollment
History of intra-abdominal abscess, abdominal fistula, gastrointestinal perforation, or active peptic ulcer disease
Bleeding disorder or coagulopathy
Serious non-healing wound, ulcer or bone fracture
Major surgical procedure, open biopsy, or traumatic injury within 4 weeks prior to enrollment or anticipation of need for surgery during the study
Known active infection with HIV, hepatitis B or C
History of splenectomy
History of Crohn's disease or ulcerative colitis
History of organ transplantation
Evidence of immunodeficiency or immune suppression
Any Autoimmune disease
Active infection
Concurrent malignancy
Pregnant or nursing
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There is 1 Location for this study
Washington District of Columbia, 20007, United States
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