Colorectal CancerPhase 2NCT00569790
Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer
A Phase 2 study testing S-1, Irinotecan, Bevacizumab in people with Colorectal Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- S-1, Irinotecan, 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
- 53 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2007to Mar 2010
- 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 20 years and older
- 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
- Total bilirubin ≤1.5 mg/dL
- 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.
Japan1 site
Hokkaido University Hospital (Hokkaido Gastrointestinal Cancer Study Group)
Sapporo, Hokkaido, 060-8038
About this study
The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- S-1, Irinotecan, Bevacizumab
- Keywords
- 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-1, Irinotecan, BevacizumabDrug
S-1 is administered orally on days 1 to 14 of a 28-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).
Irinotecan 100 mg/m2 is administered by intravenous infusion on days 1 and 15. Bevacizumab 5 mg/kg (body weight)is administered by intravenous infusion on days 1 and 15.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | S-1, Irinotecan, Bevacizumab Receives: Drug: S-1, Irinotecan, Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: any time
Secondary outcomes (1)
Progression-free survival, Response rate, Overall survival, Treatment situation
Measured: every course for first three courses, then every other course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshito Komatsu, Principal investigator, Hokkaido University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569790
- Sponsor's protocol ID
- 01023018
- Status last verified
- Nov 2012
- First submitted
- 5 Dec 2007
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Komatsu Y, Yuki S, Sogabe S, Fukushima H, Nakatsumi H, Kobayashi Y, Iwanaga I, Nakamura M, Hatanaka K, Miyagishima T, Kudo M, Munakata M, Meguro T, Tateyama M, Sakata Y. Phase II study of combined chemotherapy with irinotecan and S-1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer. Acta Oncol. 2012 Sep;51(7):867-72. doi: 10.3109/0284186X.2012.682629. Epub 2012 May 4.
PubMed 22554343
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00569790
- Acronym / sponsor ID
- 01023018
- Conditions
- Colorectal Cancer
- Keywords
- S-1, Irinotecan, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Dec 2007 (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.
The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1, Irinotecan, BevacizumabS-1, Irinotecan, Bevacizumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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-1, Irinotecan, BevacizumabS-1 is administered orally on days 1 to 14 of a 28-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). Irinotecan 100 mg/m2 is administered by intravenous infusion on days 1 and 15. Bevacizumab 5 mg/kg (body weight)is administered by intravenous infusion on days 1 and 15. | Drug | 1 |
Primary outcome
Safety
Time frame: any time
1 secondary outcome
Progression-free survival, Response rate, Overall survival, Treatment situation
Time frame: every course for first three courses, then every other course
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 2 Nov 2012.
- Derived from this study: PubMed 22554343Komatsu Y, Yuki S, Sogabe S, Fukushima H, Nakatsumi H, Kobayashi Y, Iwanaga I, Nakamura M, Hatanaka K, Miyagishima T, Kudo M, Munakata M, Meguro T, Tateyama M, Sakata Y. Phase II study of combined chemotherapy with irinotecan and S-1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer. Acta Oncol. 2012 Sep;51(7):867-72. doi: 10.3109/0284186X.2012.682629. Epub 2012 May 4.
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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.
Yoshito Komatsu principal investigator
Hokkaido University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1, Irinotecan, Bevacizumab in people with Colorectal Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site 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 18 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: finished, as of the sponsor's last update on 2 Nov 2012. 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 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 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 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?
Safety (time frame: any time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00569790, which also lists 1 linked publication.
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 2 Nov 2012.