Colorectal CancerPhase 1/2NCT00345761
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
A Phase 1/2 study testing Bevacizumab, Oxaliplatin and Capecitabine in people with Colorectal Cancer, run by Chugai Pharmaceutical at 4 sites in Japan.
Trial summary
This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Bevacizumab, Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesJapan
- Study dates
- Feb 2006to Jul 2010
- Phase
- Phase 1/2
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 20-74 years of age
- Histologically confirmed colorectal cancer
- Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease
- At least one measurable lesion according to RECIST
Who cannot join
- Evidence of clinically detectable ascites at study treatment start
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.
- Evidence of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer, or bone fracture
- Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Hokkaido Region
Hokkaido, Hokkaido
Kanto Region
Kanto, Kanto
Kinki Region
Kinki, Kinki
Tokai Region
Tōkai, Tokai
About this study
Official title: Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer
This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
Read the detailed description
This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab, Oxaliplatin, Capecitabine
- Keywords
- Advanced and/or metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
OxaliplatinDrug
130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
CapecitabineDrug
2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Step 1 | Experimental | Not described Receives: Drug: Oxaliplatin; Drug: Capecitabine |
| Step 2 | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine |
| Step 3 | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: event driven
Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Measured: throughout study
Secondary outcomes (9)
time to progression
Measured: event driven
overall survival
Measured: event driven
time to response
Measured: event driven
duration of response
Measured: event driven
concentrations of R340 and its metabolites
Measured: throughout study
concentrations of platinum
Measured: throughout study
concentrations of bevacizumab
Measured: throughout study
concentrations of vascular endothelial growth factor (VEGF)
Measured: throughout study
concentrations of anti-bevacizumab antibody
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2008
- Study completionJul 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yakult Honsha Co., LTD
- Investigators
- Yuji Hayashi, Study chair, Clinical Development Department 3, Group 6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345761
- Sponsor's protocol ID
- JO19380
- Status last verified
- Aug 2010
- First submitted
- 27 Jun 2006
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00345761
- Acronym / sponsor ID
- JO19380
- Conditions
- Colorectal Cancer
- Keywords
- Advanced and/or metastatic colorectal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- Feb 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 28 Jun 2006 (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.
This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
Detailed description
This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Step 1 | Experimental | Drug: Oxaliplatin, Drug: Capecitabine |
| Step 2 | Experimental | Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine |
| Step 3 | Experimental | Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients 20-74 years of age
- Histologically confirmed colorectal cancer
- Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease
- At least one measurable lesion according to RECIST
Key exclusion criteria (5 listed)
- Evidence of clinically detectable ascites at study treatment start
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.
- Evidence of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer, or bone fracture
- Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration
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 |
|---|---|---|
| Bevacizumab7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks) | Drug | Step 2, Step 3 |
| Oxaliplatin130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks) | Drug | Step 1, Step 2, Step 3 |
| Capecitabine2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks) | Drug | Step 1, Step 2, Step 3 |
Primary outcome
Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: event driven
Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Time frame: throughout study
9 secondary outcomes
time to progression
Time frame: event driven
overall survival
Time frame: event driven
time to response
Time frame: event driven
duration of response
Time frame: event driven
concentrations of R340 and its metabolites
Time frame: throughout study
concentrations of platinum
Time frame: throughout study
concentrations of bevacizumab
Time frame: throughout study
concentrations of vascular endothelial growth factor (VEGF)
Time frame: throughout study
concentrations of anti-bevacizumab antibody
Time frame: throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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.
Yuji Hayashi study chair
Clinical Development Department 3, Group 6
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab, Oxaliplatin and Capecitabine in people with Colorectal Cancer, run by Chugai Pharmaceutical at 4 sites in Japan.
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 4 inclusion and 5 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 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: event driven). 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 16 Aug 2010.