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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00069095




Registration number
NCT00069095
Ethics application status
Date submitted
15/09/2003
Date registered
18/09/2003
Date last updated
6/10/2016

Titles & IDs
Public title
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer
Scientific title
A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer
Secondary ID [1] 0 0
NO16966
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oxaliplatin 130 mg/m^2
Treatment: Drugs - Capecitabine 1000 mg/m^2
Treatment: Drugs - Bevacizumab 7.5 mg/kg
Treatment: Drugs - Placebo for bevacizumab 7.5 mg/kg
Treatment: Drugs - Oxaliplatin 85 mg/m^2
Treatment: Drugs - Leucovorin 200 mg/m^2
Treatment: Drugs - Bevacizumab 5 mg/kg
Treatment: Drugs - Placebo for bevacizumab 5 mg/kg

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.


Treatment: Drugs: Oxaliplatin 130 mg/m^2
Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.

Treatment: Drugs: Capecitabine 1000 mg/m^2
Capecitabine was taken within 30 min after the end of breakfast and dinner.

Treatment: Drugs: Bevacizumab 7.5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.

Treatment: Drugs: Placebo for bevacizumab 7.5 mg/kg
Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.

Treatment: Drugs: Oxaliplatin 85 mg/m^2
Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.

Treatment: Drugs: Leucovorin 200 mg/m^2
Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.

Treatment: Drugs: Bevacizumab 5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.

Treatment: Drugs: Placebo for bevacizumab 5 mg/kg
Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Primary outcome [2] 0 0
PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [2] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [1] 0 0
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [1] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [2] 0 0
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [2] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [3] 0 0
PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [3] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [4] 0 0
PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [4] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [5] 0 0
PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [5] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [6] 0 0
PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [6] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [7] 0 0
Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [7] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [8] 0 0
Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [8] 0 0
Baseline until disease progression or death, approximately 2 years 6 months
Secondary outcome [9] 0 0
Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [9] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [10] 0 0
Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [10] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [11] 0 0
BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [11] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [12] 0 0
BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [12] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [13] 0 0
Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [13] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [14] 0 0
Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [14] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [15] 0 0
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [15] 0 0
Week 1 to Week 54
Secondary outcome [16] 0 0
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [16] 0 0
Week 1 to Week 54
Secondary outcome [17] 0 0
Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [17] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [18] 0 0
Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone
Timepoint [18] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [19] 0 0
Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Timepoint [19] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months
Secondary outcome [20] 0 0
Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Timepoint [20] 0 0
From baseline until disease progression/recurrence, approximately 2 years 6 months

Eligibility
Key inclusion criteria
* Adult patients = 18 years of age.
* Metastatic colorectal cancer.
* = 1 target lesion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with oxaliplatin or bevacizumab.
* Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
* Progressive disease during or within 6 months of completion of previous adjuvant therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
2035
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Camperdown
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Footscray
Recruitment hospital [7] 0 0
- Kurralta Park
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Melbourne
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- Port Macquarie
Recruitment hospital [12] 0 0
- St. Leonards
Recruitment hospital [13] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
4101 - Brisbane
Recruitment postcode(s) [4] 0 0
2050 - Camperdown
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
3002 - Melbourne
Recruitment postcode(s) [10] 0 0
3181 - Melbourne
Recruitment postcode(s) [11] 0 0
6000 - Perth
Recruitment postcode(s) [12] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [13] 0 0
2065 - St. Leonards
Recruitment postcode(s) [14] 0 0
2031 - Sydney
Recruitment postcode(s) [15] 0 0
2139 - Sydney
Recruitment outside Australia
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United States of America
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United States of America
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Connecticut
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Georgia
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Illinois
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Kentucky
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New Mexico
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Hull
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Northwood
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Sutton
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
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Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00069095
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00069095