Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Tegafur

Leucovorin

Fluorouracil

Cetuximab

Levoleucovorin

Folic Acid

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21

UFOX + Cetuximab

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16

FOLFOX4 + Cetuximab

Jean-Yves Douillard, MD PhD

This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.

A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.

Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria

BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as "Disappearance of all target lesions plus disappearance of all non-target lesions \& without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as "At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0="Not at all" to 4="Very much". For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL.

The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.

TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.

Non-protocol medical care visits and consultations

Please refer to Adverse Events section for details of individual serious adverse events and other adverse events

Merck KGaA, Darmstadt, Germany

UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21

FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.

* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16

Total

Age, Continuous

<65 years

>=65 years

Missing

Age, Customized

Sex: Female, Male

Hong Kong

Greece

Thailand

Austria

Italy

France

Mexico

Argentina

Brazil

Poland

Belgium

Australia

Germany

Region of Enrollment

Dosing of UFT/ folinic acid in the experimental arm were not directly recorded, so dosing data is not fully available in the UFOX plus cetuximab arm (36/151). Comparative conclusions on drug exposure might be impacted by a bias due to missing data.

Merck KGaA Communication Center

Intention-to-treat (ITT) population i.e. all randomized subjects .

Progression-free Survival (PFS)

ITT population i.e. all randomized subjects.

Best Overall Response (BOR)

Overall Survival (OS)

Baseline

Cycle 3

Cycle 6

Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population

Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)

Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.

QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire

Baseline: Does not increase your risk of infection

Baseline: Does not interfere with daily activities

Baseline: Does not make you vomit

Baseline: Does not give you diarrhea

Cycle 3: Does not increase your risk of infection

Cycle 3: Does not interfere with daily activities

Cycle 3: Does not make you vomit

Cycle 3: Does not give you diarrhea

Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population.

The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles

Spots Global Cancer Trial Database for ufox + cetuximab