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CompletedNCT00689624Updated Sep 28, 2015

Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer

A Phase 2 interventional study of Irinotecan and Leukovorin in Metastatic Colorectal Cancer, sponsored by University Hospital of Crete. Completed at 1 site in Greece. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-09-28.

Sponsored by University Hospital of Crete · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

Read the detailed description

The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab

02

Conditions studied

  • Metastatic Colorectal Cancer

Keywords

  • Colorectal Cancer
  • Cetuximab
  • FOLFOXIRI
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 30 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University Hospital of Crete is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with histologically proven metastatic adenocarcinoma of the colon or rectum
  • Previous chemotherapy for metastatic disease not allowed. Patients who received prior adjuvant 5-FU-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy
  • Patients with operable metastatic disease are excluded from the study
  • Age 18-70 years
  • Performance status (ECOG) 0-1
  • At least one bidimensionally measurable lesion of >= 2cm
  • Life expectancy of at least 6 months
  • Adequate hematologic parameters (absolute neutrophil count >= 1.5x109/L and platelets >=100x109/L)
  • Creatinine and total bilirubin \< 1.25 times the upper limit of normal
  • Aspartate and alanine aminotransferase \< 3.0 times the upper limit of normal (\<5 times in case of liver mets)

Exclusion criteria

Exclusion Criteria:

  • Absence of active infection or malnutrition (loss of more than 20% of the body weight)
  • No history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
  • Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields.
  • Patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded.
  • All patients will have to sign written informed consent in order to participate in the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    1

    FOLFOXIRI+Erbitux

    Drug: Irinotecan · Drug: Leukovorin · Drug: Oxaliplatin · Drug: 5-FLUOROURACIL · Drug: Cetuximab

Interventions

  • DrugIrinotecan

    Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1

    Also known as: CPT-11, Campto

  • DrugLeukovorin

    Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3

    Also known as: LV

  • DrugOxaliplatin

    Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV

    Also known as: LoHP, Eloxatin

  • Drug5-FLUOROURACIL

    5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3

    Also known as: 5-FU

  • DrugCetuximab

    Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

    Also known as: Erbitux

06

What researchers measure

Primary outcomes

  1. Objective Response Rate

    Time frame: 2 months

Secondary outcomes

  1. Resectability rates

    Time frame: Resectability at the end of treatment (4 or 6 months from the entry to the study)

  2. Time to Tumor Progression

    Time frame: 1 year

  3. Overall Survival

    Time frame: 1 year

  4. Toxicity profile

    Time frame: Toxicity assessment on each chemotherapy cycles (every 15 days)

  5. Pharmacogenomic analysis

    Time frame: During the treatment

  6. Q-Twist analysis of Quality of life

    Time frame: Quality of life assessment every 8 weeks

07

Study locations

1 site
  • University Hospital of Crete
    Heraklion, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00689624
Lead sponsor
University Hospital of Crete
Responsible party
Vassilis Georgoulias, MD (MD, University Hospital of Crete) — Principal investigator
First posted
Jun 3, 2008
Start date
Jul 2007
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Sep 28, 2015

Study contacts

John Souglakos, MD
principal investigator · University Hospital of Crete

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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