Clinical trial NCT00689624: Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer
Official title: A Triplet Combination With Irinotecan Plus Oxaliplatin,Continuous Infusion 5-Fluorouracil And Leucovorin Plus Cetuximab As First Line Treatment In Metastatic Colorectal Cancer. A Pilot Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal Cancer
Cetuximab
FOLFOXIRI
Lead sponsor: University Hospital of Crete
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 2 months
Secondary outcomes:
measure: Resectability rates
timeFrame: Resectability at the end of treatment (4 or 6 months from the entry to the study)
measure: Time to Tumor Progression
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
measure: Toxicity profile
timeFrame: Toxicity assessment on each chemotherapy cycles (every 15 days)
measure: Pharmacogenomic analysis
timeFrame: During the treatment
measure: Q-Twist analysis of Quality of life
timeFrame: Quality of life assessment every 8 weeks
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
Study officials:
affiliation: University Hospital of Crete
name: John Souglakos, MD
role: PRINCIPAL_INVESTIGATOR
References: