Metastatic Colorectal CancerPhase 1SIRB2NCT03380689
Phase I Study of Biweekly SIRB Regimen for Metastatic Colorectal Cancer
A Phase 1 study testing S-1, Irinotecan and Bevacizumab in people with Metastatic Colorectal Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
Phase I Study of biweekly combination therapy with S-1, Irinotecan, and Bevacizumab as 1-line Chemotherapy in Patients With Advanced Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- S-1, Irinotecan 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2018to 5 Jan 2019
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
- Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
- Age ≥20 years
- Life expectancy of at least 3 months
- ECOG PS of 0 or 1
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- Adequate function of major organs as defined below:
- Hemoglobin ≥9.0g/dL
- White blood cell count ≥3,500/mm3
- Neutrophil count ≥1,500/mm3
- Platelet count ≥100,000/mm3
- AST and ALT ≤100 U/L (<200 U/L in patients with liver metastasis)
- Serum creatinine ≤1.2 mg/dL
- Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min (reduce initial dosage by one step if ≥50 but <80 mL/min)
- Able to take capsules orally.
- No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
- Voluntary written informed consent.
Who cannot join
- Serious drug hypersensitivity or a history of drug allergy
- Active double cancer
- Active infections (e.g., patients with pyrexia of 38℃ or higher)
- History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
- Uncontrolled hypertension
- Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
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- Moderate or severe ascites or pleural effusion requiring treatment
- Watery diarrhea
- Treatment with flucytosine or atazanavir sulfate
- Metastasis to the CNS
- Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
- Severe mental disorder
- Continuous treatment with steroids
- Urine dipstick for proteinuria should be <2+
- Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
- Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
- Long-term daily treatment with aspirin (>325 mg/day)
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- Judged ineligible for participation in the study by the investigator for safety reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Combination Therapy With S-1, Irinotecan, and Bevacizumab as 1-line Chemotherapy in Patients With Advanced Colorectal Cancer.
Phase I Study of biweekly combination therapy with S-1, Irinotecan, and Bevacizumab as 1-line Chemotherapy in Patients With Advanced Colorectal Cancer.
Read the detailed description
In several clinical studies from Japan and South Korea, the combination regimen of S-1 and irinotecan has shown efficacy in the treatment of advanced colorectal cancer, and a Phase III study（TRICOLORE） showed that the combination therapy with S-1/irinotecan/bevacizumab (a 3-week regimen [SIRB] or 4-week regimen [IRIS/bevacizumab]) is not inferior to the oxaliplatin-based standard treatment (mFOLFOX6/bevacizumab or CapeOX/bevacizumab) in patients with metastatic colorectal cancer who had not previously received chemotherapy. Here, we design this phase I study to explore the Chinese population's tolerability and efficacy of Biweekly SIRB Regimen(S-1/irinotecan/bevacizumab) and to explore the recommended dose of irinotecan in this regimen.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- S-1, Irinotecan, 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.
S-1Drug
Also called S1
- S-1 is administered orally on days 1 to 7 of a 14-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
IrinotecanDrug
Also called CPT-11
- CPT-11 was administrated as a 90-min intravenous infusion on day 1 of a 14-day cycle. Five escalating dose levels of CPT-11 were prepared, at an initial dose of 75mg/m2/day (level 1), stepping up to 100 (level 2), 125 (level 3), 150 (level 4) or 175 (level 5) mg/m2/day.
BevacizumabDrug
Also called Avastin
- Bevacizumab (5 mg/kg) is administered by intravenous infusion over the course of 30 to 90 min on day 1 of each 2-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| SIRB2 | Experimental | Biweekly combination therapy with S-1, Irinotecan, and Bevacizumab Receives: Drug: S-1; Drug: Irinotecan; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerance dose
Maximum tolerance dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DTL reported.
Measured: From enrollment to completion of study. Estimated about 12 months.
Secondary outcomes (4)
Dose limiting toxicity
Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria.
Measured: From enrollment to completion of study. Estimated about 12 months.
Objective response rate
Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
Measured: From enrollment to 6 months after treatment.
Progression-free survival
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
Measured: From enrollment to progression of disease. Estimated about 6 months.
Overall survival
The length of time from enrollment until the time of death (OS, overall survival).
Measured: From enrollment to death of patients. Estimated about 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start5 Jan 2018 (estimated)
- Primary completion5 Jul 2018 (estimated)
- Study completion5 Jan 2019 (estimated)
Why it stopped: There is no fund to support it
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rongbo Lin, MD, Study chair, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380689
- Sponsor's protocol ID
- FNF008
- Acronym
- SIRB2
- Status last verified
- Dec 2017
- First submitted
- 17 Dec 2017
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Combination Therapy With S-1, Irinotecan, and Bevacizumab as 1-line Chemotherapy in Patients With Advanced Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT03380689
- Acronym / sponsor ID
- SIRB2 / FNF008
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There is no fund to support it
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 5 Jan 2018 (estimated)
- Primary completion
- 5 Jul 2018 (estimated)
- Study completion
- 5 Jan 2019 (estimated)
- First posted
- 21 Dec 2017 (actual)
- 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.
Phase I Study of biweekly combination therapy with S-1, Irinotecan, and Bevacizumab as 1-line Chemotherapy in Patients With Advanced Colorectal Cancer.
Detailed description
In several clinical studies from Japan and South Korea, the combination regimen of S-1 and irinotecan has shown efficacy in the treatment of advanced colorectal cancer, and a Phase III study（TRICOLORE） showed that the combination therapy with S-1/irinotecan/bevacizumab (a 3-week regimen [SIRB] or 4-week regimen [IRIS/bevacizumab]) is not inferior to the oxaliplatin-based standard treatment (mFOLFOX6/bevacizumab or CapeOX/bevacizumab) in patients with metastatic colorectal cancer who had not previously received chemotherapy. Here, we design this phase I study to explore the Chinese population's tolerability and efficacy of Biweekly SIRB Regimen(S-1/irinotecan/bevacizumab) and to explore the recommended dose of irinotecan in this regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIRB2 | Experimental | Drug: S-1, Drug: Irinotecan, Drug: BevacizumabBiweekly combination therapy with S-1, Irinotecan, and Bevacizumab |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
- Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
- Age ≥20 years
- Life expectancy of at least 3 months
Key exclusion criteria (19 listed)
- Serious drug hypersensitivity or a history of drug allergy
- Active double cancer
- Active infections (e.g., patients with pyrexia of 38℃ or higher)
- History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
- Uncontrolled hypertension
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 |
|---|---|---|
| S-1Also: S1- S-1 is administered orally on days 1 to 7 of a 14-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2). | Drug | SIRB2 |
| IrinotecanAlso: CPT-11- CPT-11 was administrated as a 90-min intravenous infusion on day 1 of a 14-day cycle. Five escalating dose levels of CPT-11 were prepared, at an initial dose of 75mg/m2/day (level 1), stepping up to 100 (level 2), 125 (level 3), 150 (level 4) or 175 (level 5) mg/m2/day. | Drug | SIRB2 |
| BevacizumabAlso: Avastin- Bevacizumab (5 mg/kg) is administered by intravenous infusion over the course of 30 to 90 min on day 1 of each 2-week cycle. | Drug | SIRB2 |
Primary outcome
Maximum tolerance dose
Time frame: From enrollment to completion of study. Estimated about 12 months.
Maximum tolerance dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DTL reported.
4 secondary outcomes
Dose limiting toxicity
Time frame: From enrollment to completion of study. Estimated about 12 months.
Objective response rate
Time frame: From enrollment to 6 months after treatment.
Progression-free survival
Time frame: From enrollment to progression of disease. Estimated about 6 months.
Overall survival
Time frame: From enrollment to death of patients. Estimated about 1 year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
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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.
Rongbo Lin, MD study chair
Fujian Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-1, Irinotecan and Bevacizumab in people with Metastatic Colorectal Cancer, run by Fujian Cancer Hospital at 1 site in China.
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 17 inclusion and 19 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: withdrawn, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Maximum tolerance dose (time frame: From enrollment to completion of study. Estimated about 12 months.). 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 8 Mar 2021.