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

Oxaliplatin

Bevacizumab

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

bevacizumab [Avastin]

1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle

capecitabine [Xeloda]

oxaliplatin

Clinical Trials

This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.

A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer

Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.

Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.

Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.

Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.

Duration of stable response (CR, PR, or stable disease \[SD\]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.

Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.

TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).

TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.

TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.

TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.

OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.

OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.

Hoffmann-La Roche

All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.

Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Bevacizumab + Oxaliplatin + Capecitabine

Age, Continuous

Sex: Female, Male

Safety population: all participants who received at least one dose of one study medication.

Medical Communications

Intent to Treat (ITT) Population: all participants who signed the informed consent, were assigned a study patient number, and who were administered at least 1 dose of 1 study medication.

Percentage of Participants With Objective Response (OR)

ITT population; only participants with a best overall response of CR or PR were included in the analysis.

Duration of Response - Percentage of Participants With an Event by 24 Months

ITT Population; only participants with a best overall response of CR or PR were included in the analysis.

Duration of Response

ITT Population; only participants with a best overall response of CR, PR, or SD were included in the analysis.

Duration of Stable Disease - Percentage of Participants With an Event by 24 Months

Cycle 1 (28-Day Cycle) Participants received 5 milligrams/kilograms (mg/kg) bevacizumab intravenously (IV) on Days 1 and 15; 40 mg/meter\^2 (mg/m\^2) oxaliplatin IV on Days 1, 8, 15, and 22; and 2000 mg/m\^2 capecitabine orally (PO) in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14 followed by a rest period on Days 15 through 28. Cycle 1 was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

ITT Population. 5 participants were not assessed as they did not reach the 3 month time-point.

Percentage of Participants by Best Overall Response

ITT Population: only participants with a best overall response of CR, PR, or SD were included in the analysis.

Duration of Stable Disease

Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months

Time to Treatment Failure

Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months

Time to Progression

Overall Survival (OS) - Percentage of Participants With an Event by 24 Months

Overall Survival

Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m\^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial