Know Cancer

or
forgot password

A Phase II Trial of Radioimmunotherapy (Y-90 M5A) Following Hepatic Resection and FOLFIRI or FOLFOX Chemotherapy [+/-BEVACIZUMAB], or Xelox for Metastatic Colorectal Carcinoma to the Liver


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

Thank you

Trial Information

A Phase II Trial of Radioimmunotherapy (Y-90 M5A) Following Hepatic Resection and FOLFIRI or FOLFOX Chemotherapy [+/-BEVACIZUMAB], or Xelox for Metastatic Colorectal Carcinoma to the Liver


PRIMARY OBJECTIVES:

I. To determine the progression free survival in colorectal cancer patients after hepatic
resection of liver metastases and FOLFOX or leucovorin calcium, fluorouracil, and irinotecan
hydrochloride (FOLFIRI) chemotherapy [+/- Bevacizumab], or capecitabine and oxaliplatin
(XELOX),followed by intravenous (IV) yttrium-90 (90Y) M5A anti-CEA antibody.

SECONDARY OBJECTIVES:

I. To study the feasibility and toxicities of such adjuvant therapy following resection
and/or ablation of liver metastases and FOLFOX chemotherapy.

II. To evaluate the biodistribution, clearance and metabolism of 90Y and 111In (indium-111)
M5A administered IV.

OUTLINE:

FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin
calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV
over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

RADIOIMMUNOTHERAPY (RIT): Within 4-12 weeks after completion of post-hepatic resection
therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV
over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease
progression or unacceptable toxicity.

NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy
comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours,
fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes.
Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed up at 3 and 6 months.


Inclusion Criteria:



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

- Patients must have histological confirmation of colorectal carcinoma

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

- Patients will be enrolled on this trial after resection of hepatic metastases
combined with FOLFIRI or FOLFOX [+/- Bevacizumab], or XELOX; patients may have
received a maximum of 12 cycles of FOLFIRI or FOLFOX [+/- Bevacizumab], or XELOX,
which includes chemotherapy prior to and post hepatic resection

- Prior radiotherapy, immunotherapy, or chemotherapy must have been completed between
4-12 weeks prior to patient entry on this study and patients must have recovered from
all expected acute side effects of the prior therapy

- Hemoglobin >= 10 gm %; patients may be transfused to reach a hemoglobin >= 10 gm %

- White blood cell (WBC) >= 4000/uL

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelets >= 150,000/ul

- Patients may have history of prior malignancy for which the patient has been
disease-free for five years; basal or squamous cell skin cancers or carcinoma in situ
of the cervix are allowed regardless of diagnosis date

- Patients must have no prior history of radiation therapy to the liver (includes 90Y
microsphere therapy)

- Patients must have a total bilirubin =< 1.5 mg/dL

- Serum creatinine of =< 1.5 x upper limit of normal (ULN)

- Patients must have had < 40% liver resected at the close of completion of the hepatic
resection; this will be verified retrospectively

- Serum human immunodeficiency virus (HIV) testing and hepatitis B surface antigen and
hepatitis C antibody testing must be negative

- 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

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

- Computed tomography (CT) scan restaging done prior to RIT must demonstrate no
evidence of progressive disease

- The patient must be seen in consultation by the radiation oncologist who will be
administering the radiolabeled antibody therapy and must be informed of the potential
risks and side effects of the therapy, and informed consent must be documented in the
consultation note

Exclusion Criteria:

- Patients that 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) which is either poorly controlled with
currently available treatment or which is of such severity that the investigators
deem it unwise to enter the patient on protocol shall be ineligible

- Chronic active hepatitis, cirrhosis, or chemotherapy steatohepatitis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates.

Outcome Time Frame:

1 year after completion of study treatment

Safety Issue:

No

Principal Investigator

Jeffrey Wong

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

09053

NCT ID:

NCT01320683

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Liver Metastases
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

Name

Location

City of Hope Medical CenterDuarte, California  91010