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Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases


Phase 2
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases


OBJECTIVES:

Primary

- Determine the efficacy of this regimen by the measurement of objective response rate
(RECIST criteria).

Secondary

- Determine the toxicity of this regimen.

- Evaluate the duration of tumor response.

- Determine the duration and rate of tumor control.

- Determine the rate of secondary resectability of hepatic metastases.

- Evaluate progression-free survival

- Determine rate of progression of the tumor.

- Determine overall survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour, leucovorin calcium IV over 2 hours, and
fluorouracil IV continuously over 46 hours. Patients also receive oxaliplatin by hepatic
arterial infusion over 2 hours. Treatment continues for at least 3 months in the absence of
disease progression or unacceptable toxicity.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary cancer of the colon or rectum

- Isolated hepatic metastases

- Not amenable to curative resection or requirement for complex and or larger
(i.e., > 4 liver segments) liver resection

- Measurable disease (RECIST criteria)

- Original tumor must be (or have been) removed

PATIENT CHARACTERISTICS:

Inclusion criteria:

- WHO performance status 0-1

- Life expectancy > 3 months

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 1.5 times normal

- Bilirubin ≤ 1.5 times upper limit of normal

- Transaminases ≤ 5 times normal

- Not pregnant or nursing

- Fertile patients must use effective contraception

Exclusion criteria:

- Contraindication or allergy grade 3-4 to any components of the study drugs

- Peripheral neuropathy

- Intestinal occlusion or subocclusion or prior inflammatory intestinal disease

- Severe cardiac disease including any of the following:

- Symptomatic coronary disease

- Myocardial infarction in the past 6 months

- New York Heart Association grade II-IV cardiac insufficiency

- Severe arrhythmia (even if treated)

- Active or uncontrolled infection

- Other concurrent serious disorder

- Severe uncontrolled medical condition

- Other malignancy within the past 5 years or concurrently except basal cell skin
cancer or carcinoma in situ of the cervix

- Study impossible due to psychological, geographical, or social reasons

- Prisoners or patients under guardianship

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

- Prior chemotherapy except adjuvant chemotherapy comprising fluorouracil, leucovorin
calcium, capecitabine, oxaliplatin, irinotecan hydrochloride, and/or bevacizumab
(completed > 6 months ago if oxaliplatin- or irinotecan-based)

- Prior epidermal growth factor (EGF), monoclonal antibody inhibiting transduction of
EGF receptor (EGFR), or any other treatment targeting the EGFR

- Other concurrent anticancer immunotherapy, chemotherapy, or hormone therapy

- Participation in another study in the past 30 days

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy: objective tumor response rate (RECIST criteria)

Safety Issue:

No

Principal Investigator

David Malka, MD, PhD

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United States: Federal Government

Study ID:

CDR0000564063

NCT ID:

NCT00544349

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • recurrent colon cancer
  • stage IV rectal cancer
  • recurrent rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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