Colorectal CancerPhase 2NCT00120172
Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
A Phase 2 study testing oxaliplatin, capecitabine, bevacizumab in people with Colorectal Cancer and Neoplasm Metastasis, run by Geriatric Oncology Consortium at 5 sites in United States.
Trial summary
Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer, Neoplasm Metastasis
- What is being tested?
- oxaliplatin, capecitabine, bevacizumab
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2005to Jun 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years and above;
- Histologically or cytologically documented adenocarcinoma of the colon or rectum;
- Metastatic disease;
- Measurable disease or assessable but nonmeasurable disease allowed;
- ECOG 0-1
- No prior oxaliplatin or bevacizumab.
Show all 11Show fewer
- No prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy allowed;
- No prior fluoropyrimidine therapy (unless give in an adjuvant setting and completed at least 4 months earlier);
- No bleeding diathesis or coagulopathy
- Adequate renal and hepatic functions as per protocol;
- Signed informed consent
Who cannot join
- Clinically significant cardiovascular or peripheral vascular disease;
- Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin;
- Serious non-healing wound, ulcer, or bone fracture;
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Coeur d'Alene, Idaho, 83814
Study site
Inverness, Florida, 34452
Study site
Mission Hills, California, 91345
Study site
New Port Richey, Florida, 34652
Study site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.
Read the detailed description
Colorectal cancer is primarily a disease of the elderly, with the median age in the United States of 70 years. Age greater than 65 years at presentation is not a contraindication to standard therapies; acceptable morbidity and mortality, as well as long term survival, are achieved in this patient population. However, studies evaluating combination therapy have generally involved younger patients with high performance status scores. Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy, it would be of benefit to explore the combination of oxaliplatin, capecitabine, and bevacizumab in the treatment of older patients with colorectal cancer. Time to progression, overall response, duration of response, and toxicity profile will be evaluated. The feasibility of using a self-report geriatric assessment tool will also be assessed.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Being tested
- oxaliplatin, capecitabine, bevacizumab
- Keywords
- colorectal, metastatic, elderly, metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin, capecitabine, bevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
Secondary outcomes (4)
Overall response
Duration of response
Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startMay 2005
- Study completionJun 2006
Why it stopped: positive results from a larger study with same regimen was released.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geriatric Oncology Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Stuart Lichtman, MD, Study chair, Geriatric Oncology Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120172
- Sponsor's protocol ID
- GOC-GI-010
- Status last verified
- Nov 2007
- First submitted
- 8 Jul 2005
- Last updated
- 16 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00120172
- Acronym / sponsor ID
- GOC-GI-010
- Conditions
- Colorectal Cancer, Neoplasm Metastasis
- Keywords
- colorectal, metastatic, elderly, metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: positive results from a larger study with same regimen was released.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Geriatric Oncology ConsortiumUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 15 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.
Detailed description
Colorectal cancer is primarily a disease of the elderly, with the median age in the United States of 70 years. Age greater than 65 years at presentation is not a contraindication to standard therapies; acceptable morbidity and mortality, as well as long term survival, are achieved in this patient population. However, studies evaluating combination therapy have generally involved younger patients with high performance status scores. Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy, it would be of benefit to explore the combination of oxaliplatin, capecitabine, and bevacizumab in the treatment of older patients with colorectal cancer. Time to progression, overall response, duration of response, and toxicity profile will be evaluated. The feasibility of using a self-report geriatric assessment tool will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age 65 years and above;
- Histologically or cytologically documented adenocarcinoma of the colon or rectum;
- Metastatic disease;
- Measurable disease or assessable but nonmeasurable disease allowed;
- ECOG 0-1
Key exclusion criteria (3 listed)
- Clinically significant cardiovascular or peripheral vascular disease;
- Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin;
- Serious non-healing wound, ulcer, or bone fracture;
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 |
|---|---|---|
| oxaliplatin, capecitabine, bevacizumab | Drug | – |
Primary outcome
To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
4 secondary outcomes
Overall response
Duration of response
Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores
Results and safety
The study was stopped early (reason given: positive results from a larger study with same regimen was released.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2007.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Stuart Lichtman, MD study chair
Geriatric Oncology Consortium
5 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 oxaliplatin, capecitabine, bevacizumab in people with Colorectal Cancer and Neoplasm Metastasis, run by Geriatric Oncology Consortium at 5 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 11 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early (reason given: positive results from a larger study with same regimen was released.). Results are not available in the source record.
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?
To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.. 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 16 Nov 2007.