Advanced Gastric CancerPhase 2NCT01238055
Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer
A Phase 2 study testing Docetaxel + Sunitinib and Docetaxel only in people with Advanced Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Docetaxel + Sunitinib and Docetaxel only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to Oct 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
- patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
- prior chemotherapy wit fluoropyrimidine and platinum
- measurable or evaluable disease according to RECIST
- age, 18 years or older
- ECOG performance status 0 - 2
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- adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL
- life expectancy of ≥ 3 months
- signed written informed consent
Who cannot join
- more than one prior chemotherapy for metastatic disease
- severe co-morbid illness and/or active infections
- NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment
- preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
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- active and uncontrollable bleeding from gastrointestinal tract
- known history of hypersensitivity to study drugs
- prior treatment with sunitinib
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum
The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.
Read the detailed description
This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Docetaxel + Sunitinib, Docetaxel only
- Keywords
- advanced gastric cancer, sunitinib, docetaxel, fluoropyrimidine platinum based chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + SunitinibDrug
Docetaxel 60 mg/m2 iv, every 3 weeks
Sunitinib 37.5 mg qd daily, every 3 weeks
Docetaxel onlyDrug
Docetaxel 60 mg/m2 iv
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + Sunitinib | Experimental | Docetaxel and Sunitinib Receives: Drug: Docetaxel + Sunitinib |
| Docetaxel | Active comparator | Docetaxel only Receives: Drug: Docetaxel only |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression
Measured: every 6 weeks
Secondary outcomes (3)
Response rate
Measured: 12 months
Overall survival
Measured: 12 months
Progression free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startNov 2008
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeeyun Lee, M.D., Ph.D., Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238055
- Sponsor's protocol ID
- 2008-09-031
- Status last verified
- Jan 2012
- First submitted
- 7 Jan 2010
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum
- ClinicalTrials.gov ID
- NCT01238055
- Acronym / sponsor ID
- 2008-09-031
- Conditions
- Advanced Gastric Cancer
- Keywords
- advanced gastric cancer, sunitinib, docetaxel, fluoropyrimidine platinum based chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Nov 2010 (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 Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.
Detailed description
This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + Sunitinib | Experimental | Drug: Docetaxel + SunitinibDocetaxel and Sunitinib |
| Docetaxel | Active comparator | Drug: Docetaxel onlyDocetaxel only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
- patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
- prior chemotherapy wit fluoropyrimidine and platinum
- measurable or evaluable disease according to RECIST
- age, 18 years or older
Key exclusion criteria (9 listed)
- more than one prior chemotherapy for metastatic disease
- severe co-morbid illness and/or active infections
- NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment
- preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
- pregnant or lactating women
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 |
|---|---|---|
| Docetaxel + SunitinibDocetaxel 60 mg/m2 iv, every 3 weeks Sunitinib 37.5 mg qd daily, every 3 weeks | Drug | Docetaxel + Sunitinib |
| Docetaxel onlyDocetaxel 60 mg/m2 iv | Drug | Docetaxel |
Primary outcome
time to progression
Time frame: every 6 weeks
3 secondary outcomes
Response rate
Time frame: 12 months
Overall survival
Time frame: 12 months
Progression free survival
Time frame: 12 months
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 9 Apr 2013.
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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.
Jeeyun Lee, M.D., Ph.D. principal investigator
Samsung Medical Center, Seoul, Korea
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 Docetaxel + Sunitinib and Docetaxel only in people with Advanced Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 9 inclusion and 9 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 9 Apr 2013. 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 South Korea. 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?
time to progression (time frame: every 6 weeks). 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 9 Apr 2013.