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Phase I Trial of Radioimmunotherapy (Y-90 M5A) in Combination With FOLFIRI and Bevacizumab Chemotherapy for Metastatic Colorectal Carcinoma

Phase 1
18 Years
Open (Enrolling)
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

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Trial Information

Phase I Trial of Radioimmunotherapy (Y-90 M5A) in Combination With FOLFIRI and Bevacizumab Chemotherapy for Metastatic Colorectal Carcinoma

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of a combination of FOLFIRI
chemotherapy, and intravenous yttrium-90 (90Y) M5A anti-CEA antibody.

SECONDARY OBJECTIVES:I. To study the progression free survival and response rate of this
combined treatment in patients with stage IV colorectal cancer.II. To evaluate the
biodistribution, clearance and metabolism of 90Y and 111In (indium-111) M5A administered

OUTLINE: This is a dose-escalation study of yttrium Y 90 DOTA anti-CEA monoclonal antibody
M5A. Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV
over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90
minutes once every 2 weeks. Patients also receive yttrium Y 90 DOTA anti-CEA monoclonal
antibody M5A IV over 25 minutes once in weeks 3 and 9. Treatment continues in the absence of
disease progression or unacceptable toxicity.

Inclusion Criteria:

- Patients must have a Karnofsky performance status of > 60%

- Patients must have histological confirmation of colorectal carcinoma with stage IV
disease or with unresectable disease

- Patients must have colorectal tumors that produce CEA as documented by either
immunohistochemistry or by an elevated serum CEA

- Prior radiotherapy, immunotherapy, or chemotherapy must have been completed no less
than 28 days prior to patient entry on this study and patients must have recovered
from all acute expected side effects of the prior therapy. For patients who have
undergone port placement, study treatment initiation must be at least 7 days post
port placement

- Adequate bone marrow function as evidenced by hemoglobin > 10 g/dL, WBC > 4000/ul, an
absolute granulocyte count of > 1,500/mm^3, and platelets > 150,000/ul; patients may
be transfused to reach a hemoglobin > 10 g/dL

- In the dose-escalation phase, patients may have had a history of a prior malignancy;
for the dose-expansion cohort, patients may have history of prior malignancy for
which they have been disease free for five years with the exception of basal or
squamous cell skin cancers or carcinoma in situ of the cervix

- Patients must have a total bilirubin < 1.5 mg/dL and a serum creatinine of < 2.0

- If a patient has previously received antibody, then serum anti-antibody testing must
be negative

- Serum HIV testing and hepatitis B surface antigen and C antibody testing must be

- Women of childbearing potential must have a negative serum pregnancy test prior to
entry and while on study must be practicing an effective form of contraception

- Patients must have measurable disease as defined by the modified RECIST criteria

Exclusion Criteria:

- Patients who have received radiation therapy to greater than 50% of their bone marrow

- Patients with any nonmalignant intercurrent illness (example cardiovascular,
pulmonary, or central nervous system disease) that is either poorly controlled with
currently available treatment or that is of such severity that the investigators deem
it unwise to enter the patient on protocol shall be ineligible

- Patients with > 2+ protein by dipstick should undergo a 24 hour urine collection;
patients with > 1gram proteinuria/ 24 hours are not eligible

- Patients may have received neoadjuvant and/or adjuvant chemotherapy and/or
radiotherapy and present to the study in relapse; otherwise, no prior therapy is

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of yttrium-90 (90Y) M5A anti-CEA antibody when given in combination with FOLFIRI chemotherapy and bevacizumab

Outcome Time Frame:

1 year post treatment

Safety Issue:


Principal Investigator

Jeffrey Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

Related Keywords:

  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



City of Hope Medical Center Duarte, California  91010