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A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Unresectable Liver Metastasis

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Trial Information

A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis

We will include the patients with unresectable liver-only metastatic disease independent of
EGFR status. The results of this study will show the resection rate with neoadjuvant
treatment in patients with colorectal cancer with liver-only metastasis.

Restaging including CT after #3, #6, #9, and #12 cycles of FOLFOX + Cetuximab

If any time, patients have PD, Off-study SD, Continue study treatment until resectable, up
to #12 cycles, PD, or toxicities PR or more, If resectable, go to surgery : resection of
liver metastasis and primary tumor, if present If unresectable, continue until resectable,
up to #12 cycles, PD, or toxicities

Overall, a total of 12 cycles of treatment including neoadjuvant therapy will be given
either before, after or without surgery.

CT scans will be performed every 3 cycles during the first 12 cycles (6 months). After that,
CT scans will be performed every 2 months for another 6 months, then every 3 months for 6
months, then once a year or earlier if a PD is probable.

AEs will be evaluated once every cycle and during the CT evaluation visit.. Patients that
can only undergo R1 resection or are unable to get surgery at all, will be evaluated
regularly until PD.

Radiofrequency ablation (RFA) may be allowed as a palliative local therapy in patients that
are suitable for it. RFA is not considered equal to a resection.

Inclusion Criteria:

- Histologically proven colorectal cancer with metastatic lesion(s) in the liver that
is (are) unresectable

- Age ≥ 18

- ECOG performance 0 - 1

- Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin
< 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet
> 100,000/ul, absolute neutrophil count ≥ 1,500/ul)

- At least one measurable lesion by RECIST criteria

- Written informed consent

Exclusion Criteria:

- Resectable liver metastasis

- Extrahepatic metastases, regardless of their resectability

- Chronic active hepatitis or cirrhosis

- Prior therapy for metastatic disease

- Pregnant or lactating women

- Uncontrolled medical illnesses including medically uncontrolled infection,
uncontrolled hypertension, unstable angina, symptomatic congestive heart failure,
myocardial infarction within 6 months

- Previous adjuvant FOLFOX chemotherapy

- Prior adjuvant chemotherapy, if administered within 6 months before study entry

- Known hypersensitivity reaction to any of the components of study treatment

- Prior agents directed against EGFR

- Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal
antibody therapy

- Known alcohol or drug abuse

- Participation in another clinical study within the 30 days before registration

- Peripheral neuropathy > grade 1

- Other previous malignancy with exception of a history of a previous curatively
treated basal cell carcinoma of the skin of pre-invasive carcinoma of the cervix.

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Young Suk Park, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

June 2012

Related Keywords:

  • Colorectal Cancer
  • Unresectable Liver Metastasis
  • Colorectal Cancer
  • Unresectable liver metastasis
  • Cetuximab
  • Neoadjuvant therapy
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms