Colorectal CancerPhase 2NCT00203411
Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer
A Phase 2 study testing Capecitabine (Xeloda) and Bevacizumab in people with Colorectal Cancer, run by Translational Oncology Research International at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Capecitabine (Xeloda) and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2006to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven adenocarcinoma of the colon at first diagnosis
- Stage IV disease, with at least one measurable lesion according to the RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 2
- No prior chemotherapy for metastatic colorectal cancer
- Prior adjuvant chemotherapy is permitted.
- At least 28 days since prior surgery
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- If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment and for at least 3 months thereafter.
- Required laboratory values:
- Absolute neutrophil count > 1.5 x 10^9/L
- Hemoglobin > 9.0 g/dL
- Platelet count > 100 x 10^9/L
- Creatinine < 2.0 mg/dL
- Total bilirubin < 1.5 x upper limit of normal (ULN) (Patients with documented Gilbert's syndrome are eligible.)
- Alkaline phosphatase and AST/ALT within the following parameters. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used:
- Alkaline phosphate and AST/ALT < or = ULN
- Alkaline phosphate > 1x but < or = 2.5x and AST/ALT < or = ULN
- Alkaline phosphate > 2.5x but < or = 5x and AST/ALT < or = ULN
- Alkaline phosphate < or = ULN and AST/ALT > 1x but < or = 1.5x
- Alkaline phosphate > 1x but < or = 2.5 x and AST/ALT > 1x but < or = 1.5x
- Alkaline phosphate < or = ULN and AST/ALT > 1x but < or = 2.5x
Who cannot join
- Prior chemotherapy for metastatic colorectal cancer
- Prior treatment with an anti-angiogenic agent
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Current or prior history of central nervous system or brain metastases
- Presence of neuropathy > grade 2 (NCI-Common Toxicity Criteria (CTC) version 3.0) at baseline
- Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (> grade 2) peripheral vascular disease
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- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
- Clinically significant cardiovascular disease (e.g., blood pressure [BP] > 150/100, myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning therapy
- Active infection requiring parenteral antimicrobials
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
- Inability to comply with the study protocol or follow-up procedures
- Pregnancy or lactation
- A history of a severe hypersensitivity reaction to bevacizumab, or capecitabine or other drugs formulated with polysorbate 80.
- Evidence of bleeding diathesis or coagulopathy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration or core biopsy within 7 days prior to Day 0
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- Unstable angina
- Urine protein creatinine ratio greater than or equal to 1.
- Therapeutic anticoagulation with oral anticoagulation medications, specifically coumarins
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Pacific Shores Medical Group
Long Beach, California, 90813
UCLA Medical Center
Los Angeles, California, 90095
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Wilshire Oncology Medical Group, Inc.
Pomona, California, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- Capecitabine (Xeloda), Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda)Drug
1000mg/m^2 administered orally twice daily for two weeks followed by one week rest period
BevacizumabDrug
7.5 mg/kg IV will be administered every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab Plus Capecitabine | Experimental | 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. Receives: Drug: Capecitabine (Xeloda); Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
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
Measured: 12 months
Number of Subjects Requiring Dose Modifications
Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.
Measured: 3 months
Secondary outcomes (2)
Response Rates
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
Measured: every 21 days up to 12 months
Quality of Life of Patients
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'.
Measured: Baseline, Cycle 2, and End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Oncology Research International
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Arash Naeim, MD, PhD, Study chair, University of California, Los AngelesRandy Hecht, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203411
- Sponsor's protocol ID
- TORI GI-04
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00203411
- Acronym / sponsor ID
- TORI GI-04
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Translational Oncology Research InternationalUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Mar 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab Plus Capecitabine | Experimental | Drug: Capecitabine (Xeloda), Drug: BevacizumabBevacizumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically or cytologically proven adenocarcinoma of the colon at first diagnosis
- Stage IV disease, with at least one measurable lesion according to the RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 2
- No prior chemotherapy for metastatic colorectal cancer
- Prior adjuvant chemotherapy is permitted.
Key exclusion criteria (20 listed)
- Prior chemotherapy for metastatic colorectal cancer
- Prior treatment with an anti-angiogenic agent
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Current or prior history of central nervous system or brain metastases
- Presence of neuropathy > grade 2 (NCI-Common Toxicity Criteria (CTC) version 3.0) at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine (Xeloda)1000mg/m^2 administered orally twice daily for two weeks followed by one week rest period | Drug | Bevacizumab Plus Capecitabine |
| Bevacizumab7.5 mg/kg IV will be administered every 3 weeks | Drug | Bevacizumab Plus Capecitabine |
Primary outcome
Time to Disease Progression
Time frame: 12 months
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 Requiring Dose Modifications
Time frame: 3 months
Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.
2 secondary outcomes
Response Rates
Time frame: every 21 days up to 12 months
Quality of Life of Patients
Time frame: Baseline, Cycle 2, and End of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Naeim, MD, PhD study chair
University of California, Los Angeles
Randy Hecht, MD study chair
University of California, Los Angeles
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine (Xeloda) and Bevacizumab in people with Colorectal Cancer, run by Translational Oncology Research International at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.