Gastric AdenocarcinomaPhase 2NCT01558011
Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study
A Phase 2 study testing Capecitabine, Oxaliplatin, Docetaxel in people with Gastric Adenocarcinoma, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Capecitabine, Oxaliplatin, Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2012to Dec 2015
- 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
- Pathologically confirmed gastric adenocarcinoma.
- At least one measurable lesion in a non-irradiated area.
- No prior exposure to systemic chemotherapy for advanced gastric cancer.
- For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
- Age > 20 years old.
- ECOG Performance Status 2.
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- Life expectancy greater than 12 weeks.
- Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.
- Adequate liver function : ALT \& AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN
- Adequate renal function :Creatinine < 1.5 x ULN.
- Patients must be accessible for treatment and follow-up in the participating centers.
Who cannot join
- Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
- Major surgery within two weeks prior to entering the study.
- Patients with CNS metastasis, including clinical suspicion.
- Patients who are under active or uncontrolled infections.
- Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
- Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria
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- Patients with concomitant illness that might be aggravated by chemotherapy.
- Patients who are pregnant or with breast feeding.
- Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
- Patients with hypersensitivity to any component of the chemotherapeutic regimen.
- Mental status is not fit for clinical trial
- Can not take study medication orally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study
This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
Read the detailed description
There are two primary objectives in different steps. In the first step, the primary objective of this study is to investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
In the second step, the primary objective of this study is to screen the predictive biomarkers of three different chemotherapeutic drugs and also investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Capecitabine, Oxaliplatin, Docetaxel
- Keywords
- gastric adenocarcinoma, Capecitabine and oxaliplatin (XELOX), Docetaxel and capecitabine (TX), Using genetic polymorphisms, drug metabolism and immunohistochemical stain, predict the efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, Oxaliplatin, DocetaxelDrug
Also called Capecitabine (Xeloda○R), company: Roche, Oxaliplatin (Eloxatin○R, company: Sanofi-Avantis, Docetaxel (Taxotere○R, company: Sanofi-Avantis
Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial.
Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Experimental | Chemotherapy:
Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy. Receives: Drug: Capecitabine, Oxaliplatin, Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.
Measured: Every 6 weeks
Secondary outcomes (1)
Progression-free survival
Be calculated as the duration between the first date of randomization and the date of disease recurrence or progression according to RECIST (failed), taking the status of tumor at the treatment has been completed as the reference, or death (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionDec 2015
Why it stopped: The budget issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Mackay Memorial Hospital, National Cheng-Kung University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558011
- Sponsor's protocol ID
- T3211
- Other IDs
- 100CT202
- Status last verified
- Oct 2013
- First submitted
- 5 Mar 2012
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study
- ClinicalTrials.gov ID
- NCT01558011
- Acronym / sponsor ID
- T3211
- Conditions
- Gastric Adenocarcinoma
- Keywords
- gastric adenocarcinoma, Capecitabine and oxaliplatin (XELOX), Docetaxel and capecitabine (TX), Using genetic polymorphisms, drug metabolism and immunohistochemical stain, predict the efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The budget issues.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital (TSGH), Mackay Memorial Hospital, National Cheng-Kung University Hospital
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Mar 2012 (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 is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
Detailed description
There are two primary objectives in different steps. In the first step, the primary objective of this study is to investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
In the second step, the primary objective of this study is to screen the predictive biomarkers of three different chemotherapeutic drugs and also investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Experimental | Drug: Capecitabine, Oxaliplatin, DocetaxelChemotherapy: Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed gastric adenocarcinoma.
- At least one measurable lesion in a non-irradiated area.
- No prior exposure to systemic chemotherapy for advanced gastric cancer.
- For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
- Age > 20 years old.
Key exclusion criteria (12 listed)
- Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
- Major surgery within two weeks prior to entering the study.
- Patients with CNS metastasis, including clinical suspicion.
- Patients who are under active or uncontrolled infections.
- Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
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 |
|---|---|---|
| Capecitabine, Oxaliplatin, DocetaxelAlso: Capecitabine (Xeloda○R), company: Roche, Oxaliplatin (Eloxatin○R, company: Sanofi-Avantis, Docetaxel (Taxotere○R, company: Sanofi-AvantisCapecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial. Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy. | Drug | chemotherapy |
Primary outcome
Objective response rate
Time frame: Every 6 weeks
Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.
1 secondary outcome
Progression-free survival
Time frame: Every 6 weeks
Results and safety
The study was stopped early (reason given: The budget issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Capecitabine, Oxaliplatin, Docetaxel in people with Gastric Adenocarcinoma, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 12 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 4 May 2016. 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 Taiwan. 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: The budget issues.). 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?
Objective response rate (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 4 May 2016.