A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oxaliplatin 130 mg/m^2 — DRUG
  Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
• Capecitabine 1000 mg/m^2 — DRUG
  Capecitabine was taken within 30 min after the end of breakfast and dinner.
• Bevacizumab 7.5 mg/kg — DRUG
  Bevacizumab was administered in a 30 to 90 min infusion.
• Placebo for bevacizumab 7.5 mg/kg — DRUG
  Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
• Oxaliplatin 85 mg/m^2 — DRUG
  Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.
• Leucovorin 200 mg/m^2 — DRUG
  Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.
• Fluorouracil 400 mg/m^2 — DRUG
• Bevacizumab 5 mg/kg — DRUG
  Bevacizumab was administered in a 30 to 90 min infusion.
• Placebo for bevacizumab 5 mg/kg — DRUG
  Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.

Study Details

This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m\^2 orally \[po\] twice a day \[bid\] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil \[5-FU\] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

Key Dates

First listed

Sep 18, 2003

Start date

Jul 31, 2003

Status verified

Aug 2016

Primary completion

Jan 31, 2006

Completion

Apr 30, 2009

Study Design

Enrollment

2,035 participants (actual)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: XELOX (oxaliplatin+capecitabine)
  Patients in the 2-arm part of the study received oxaliplatin 130 mg/m\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\^2 orally twice a day for the first 2 weeks of every 3 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
• Experimental: XELOX (oxaliplatin+capecitabine) + bevacizumab
  Patients in the 4-arm part of the study received oxaliplatin 130 mg/m\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\^2 orally twice a day for the first 2 weeks of every 3 week cycle + bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
• Active Comparator: FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)
  Patients in the 2-arm part of the study received oxaliplatin 85 mg/m\^2 intravenously (iv) + leucovorin 200 mg/m\^2 iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle.
• Active Comparator: FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab
  Patients in the 4-arm part of the study received oxaliplatin 85 mg/m\^2 intravenously (iv) + leucovorin 200 mg/m\^2 iv + bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle.

Primary Outcome Measure

Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4 [ Time Frame: Baseline until disease progression or death, approximately 2 years 6 months ]

Locations (49)

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