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Oxaliplatin-CPT-11-5-FU-Leucovarin + Bevacizumab and Cetuximab (OCFL-BC) as a Combination Regimen for Systemic Treatment of Advanced Colorectal Carcinoma With Potentially Resectable Liver and/or Lung Metastases. A Phase II Study

Phase 2
18 Years
70 Years
Open (Enrolling)
Colorectal Cancer, Metastatic Cancer

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Trial Information

Oxaliplatin-CPT-11-5-FU-Leucovarin + Bevacizumab and Cetuximab (OCFL-BC) as a Combination Regimen for Systemic Treatment of Advanced Colorectal Carcinoma With Potentially Resectable Liver and/or Lung Metastases. A Phase II Study



- To determine the pathological complete response (CR) rate in resected patients assessed
on lesions of less than or equal to 30 mm in size.


- To determine the clinical CR rate in all patients.

- To determine toxicity and tolerability of this regimen (pre- and postoperative

- To evaluate perioperative safety in these patients.

- To determine disease-free survival (time to progression in unresected patients) and
overall survival of the whole study population.

- To determine resectability in these patients.

- To evaluate markers that predict the occurrence of a pathological CR or a non-response
in pathological material (resected liver metastasis) and biological material collected
from these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, oxaliplatin IV
over 2 hours on days 1 and 15, irinotecan hydrochloride IV over 30 minutes on days 8 and 22,
fluorouracil IV over 24 hours on days 1, 8, 15, and 22, leucovorin calcium IV on days 1, 8,
15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every
5 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients who are able to undergo liver resection receive bevacizumab on day 1 only of course
3 and undergo liver resection 3 weeks after chemotherapy. Beginning 4 weeks after liver
resection, patients receive 2 additional courses of chemotherapy as adjuvant therapy.

Patients undergo tumor tissue and blood sample collection periodically for biological
studies. Samples are analyzed for markers that predict the occurrence of a complete
pathological response (pCR) or a non-response.

After completion of study treatment, patients are followed every 3 months for the first 2
years and then every 6 months thereafter.

Inclusion Criteria


Inclusion criteria:

- Histologically confirmed metastatic colorectal adenocarcinoma

- Bidimensionally measurable metastatic disease limited to the liver and considered
curatively resectable after response to systemic therapy as assessed by a surgical

- Additional metastatic disease to the lungs consisting of no more than 3
potentially resectable lesions allowed

- Must have at least one lesion of 30 mm or less

Exclusion criteria:

- History or evidence upon physical examination of CNS disease unless adequately
treated (e.g., uncontrolled seizure with standard medical therapy or history of


Inclusion criteria:

- Performance status ≤ 1

- Life expectancy > 12 weeks

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine 1.25 x upper limit of normal (ULN)

- Bilirubin 1.25 x ULN (1.5 x ULN if liver metastasis)

- AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastasis)

- Woman and men of childbearing age must use adequate contraception

Exclusion criteria:

- Pregnancy (positive serum pregnancy test) or lactation

- Chronic diarrhea ≥ grade 2

- Other serious illness or medical condition including any of the following:

- Unstable cardiac disease requiring treatment

- Congestive heart failure or angina pectoris even if medically controlled

- Significant arrhythmias

- History of significant neurologic or psychiatric disorders including psychotic
disorders, dementia, or seizures that would prohibit the understanding and
giving of informed consent

- Active uncontrolled infection

- Severe hypercalcemia

- Other serious underlying medical condition that could impair the ability of the
patient to participate in the study

- Neuropathy > grade 1 of any etiology

- Known DPD deficiency

- Known severe polyneuropathy

- Known allergy to Chinese hamster ovary cell proteins, other recombinant human or
humanized antibodies, any excipients of bevacizumab formulation, or any other study

- Chronic inflammatory bowel disease

- Acute or subacute intestinal occlusion

- History of previous arterial thromboembolism

- Uncontrolled hypertension

- Evidence of bleeding diathesis or coagulopathy

- Serious nonhealing wound, ulcer, or bone fracture

- History of tumor other than basocellular carcinoma of the skin

- Peripheral neuropathy > grade 1 of any origin (e.g., alcohol)

- Significant traumatic injury within 28 days prior to study treatment


Exclusion criteria:

- No prior chemotherapy for metastatic disease

- Prior adjuvant chemotherapy permitted if interval since last treatment
administration and recurrence is > 6 months

- Major surgical procedure or open biopsy within 28 days prior to study treatment or
anticipation of the need for major surgical procedure during the course of the study

- Treatment in a clinical trial within 30 days prior to study entry

- Concurrent treatment with other experimental drugs or other anticancer therapy

- Current or recent use (within 10 days prior to study treatment) of full-dose oral or
parenteral anticoagulants for therapeutic purposes

- Chronic daily treatment with aspirin (> 325 mg/day)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens

Safety Issue:


Principal Investigator

Arnaud Roth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Cantonal Universitaire de Geneve


United States: Federal Government

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • recurrent rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • stage IV colon cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • liver metastases
  • lung metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Lung Neoplasms