Study: NCT00705016

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilengitide 2000 mg once weekly
Description: Cilengitide 500 milligram (mg) will be administered as an intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by 2000 mg dose of cilengitide on Day 8 and 15 of every cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cilengitide 2000 mg twice weekly
Description: Cilengitide 2000 mg will be administered as an intravenous infusion over 60 minutes, twice weekly on Day 1, 4, 8, 11, 15, and 18 of each 3-week cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants will receive cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cetuximab
Description: Cetuximab will be administered as 250 milligram per square meter (mg/m\^2) as infusion (initial starting dose of 400 mg/m\^2) on Day 1, 8 and 15 of each 3-week treatment cycle. Cetuximab will be administered for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received Cetuximab 250 mg/m\^2 once weekly until PD, unacceptable toxicity or withdrawal for any other reason.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: Cetuximab will be administered as 250 milligram per square meter (mg/m\^2) as infusion (initial starting dose of 400 mg/m\^2) on Day 1, 8 and 15 of each 3-week treatment cycle. Cetuximab will be administered for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received Cetuximab 250 mg/m\^2 once weekly until PD, unacceptable toxicity or withdrawal for any other reason.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: Cetuximab will be administered as 250 milligram per square meter (mg/m\^2) as infusion (initial starting dose of 400 mg/m\^2) on Day 1, 8 and 15 of each 3-week treatment cycle. Cetuximab will be administered for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received Cetuximab 250 mg/m\^2 once weekly until PD, unacceptable toxicity or withdrawal for any other reason.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5-fluorouracil (5-FU)
Description: 5-FU will be administered as an intravenous continuous infusion at a dose of 1000 mg/m\^2 daily from Day 1 to 4 of each 3-week treatment cycle. 5-FU will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-fluorouracil (5-FU)
Description: 5-FU will be administered as an intravenous continuous infusion at a dose of 1000 mg/m\^2 daily from Day 1 to 4 of each 3-week treatment cycle. 5-FU will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-fluorouracil (5-FU)
Description: 5-FU will be administered as an intravenous continuous infusion at a dose of 1000 mg/m\^2 daily from Day 1 to 4 of each 3-week treatment cycle. 5-FU will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cisplatin
Description: Cisplatin will be administered as an intravenous infusion over 60 minutes, at a dose 100 mg/m\^2 on Day 1 of each 3-week treatment cycle. Cisplatin will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cisplatin will be administered as an intravenous infusion over 60 minutes, at a dose 100 mg/m\^2 on Day 1 of each 3-week treatment cycle. Cisplatin will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cisplatin will be administered as an intravenous infusion over 60 minutes, at a dose 100 mg/m\^2 on Day 1 of each 3-week treatment cycle. Cisplatin will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first.