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

Bevacizumab

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m\^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

1000mg/m\^2 administered orally twice daily for two weeks followed by one week rest period

Capecitabine (Xeloda)

7.5 mg/kg IV will be administered every 3 weeks

Arash Naeim, MD, PhD

Randy Hecht, MD

The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and capecitabine combination in frail patients with untreated metastatic colorectal cancer.

The study will evaluate the tolerability, safety, and feasibility of combination bevacizumab and capecitabine in a small number of frail patients with metastatic colorectal cancer who have a compromised performance status. Preclinical studies suggest that the combination of chemotherapy and anti-angiogenic therapy offer an increased anti-tumor effect compared with either treatment alone.

Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer

A Phase II Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Capecitabine (Xeloda) in Frail Patients With Untreated Metastatic Colorectal Cancer

Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date

Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.

Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) - a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.

The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.

The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 'Best imaginable health state' and 100 'Worst imaginable health state'.

Genentech, Inc.

Translational Oncology Research International

Systemic adverse event assessment occurred every through investigator assessment during the Treatment period

Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m\^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Bevacizumab Plus Capecitabine

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Score of 1

Score of 2

ECOG Grade Evaluated by Physical Exam 0 Fully active, able to carry on all predisease activities with restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Out of bed \> 50%
3. Capable of only limited self-care, confined to bed or chair \> 50% waking hours
4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair

Eastern Cooperative Oncology Group (ECOG)

This was a small study with only 45 participants who received study treatment. With such a small sample size the study does not have the statistical power to make categorical assessments or statements.

Dr. Arash Naeim

Time to Disease Progression

Delay in Bevacizumab Dose

Discontinuation of Bevacizumab

Delay in Capec itabineDose

Reduction of Capecitabine Dose

Discontinuation of Capecitabine

Number of Subjects Requiring Dose Modifications

Complete Response

Partial Response

Stable Disease

Progression

Not Evaluable

Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Response Rates

Baseline FACT-C Trial outcome index (TOI)

Cycle 2 FACT-C TOI

End of Study FACT-C TOI

Baseline FACT-C Composite

Cycle 2 FACT-C Composite

End of Study FACT-Composite

Baseline EQ-5D VAS

Cycle 2 EQ-5D VAS

End of Study EQ-5D VAS

Quality of Life of Patients

Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m\^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period

Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks

Treatment Period

Follow-up

Spots Global Cancer Trial Database for Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial