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A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLOFOX or FOLFIRI in Patients With Newly Diagnosed Ras Mutant Positive Metastatic Colorectal Cancer or Patients With Ras Mutant Positive Colorectal Cancer Who Have Just Completed a First Line Therapy With an Oxaliplatin or Irinotecan Plus Fluoropyrimidine and Bevacizumab Containing Regimen


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

Thank you

Trial Information

A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLOFOX or FOLFIRI in Patients With Newly Diagnosed Ras Mutant Positive Metastatic Colorectal Cancer or Patients With Ras Mutant Positive Colorectal Cancer Who Have Just Completed a First Line Therapy With an Oxaliplatin or Irinotecan Plus Fluoropyrimidine and Bevacizumab Containing Regimen


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 40YU 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 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


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 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants alive and free of progression at 4 months(patients who have undergone prior therapy) and 10 months (untreated patients)

Outcome Description:

clinical benefit rate is defined as the proportion of patients alive and free of progression at 10 months in group A or at 4 months in group B, assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.

Outcome Time Frame:

10 months

Safety Issue:

No

Principal Investigator

John L Marshall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Food and Drug Administration

Study ID:

GI-4000-05

NCT ID:

NCT01322815

Start Date:

October 2010

Completion Date:

October 2015

Related Keywords:

  • Colon Cancer
  • colon cancer
  • metastatic
  • vaccine
  • Colonic Neoplasms

Name

Location

Georgetown UniversityWashington, District of Columbia  20007-2197