Gastric CancerPhase 2NCT01167049
Xeloda Plus Paclitaxel in Gastric Cancer With Liver Metastasis
A Phase 2 study testing CAPECITABINE in people with Gastric Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant chemotherapy for gastric cancer with liver metastasis only Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- CAPECITABINE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Dec 2013
- 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
- Ambulatory males or females, aged no less than 18 years.
- ECOG performance status: 0-1.
- Histologically confirmed gastric adeno-carcinoma.
- Radiologically confirmed liver metastasis without other distant metastasis.
- No serious concomitant medical illnesses
- Life expectancy more than 3 months
Show all 9Show fewer
- Be willing and able to comply with the protocol for the duration of the study
- No Prior treatment for metastatic disease
- Give signed informed consent
Who cannot join
- not fit for the inclusion criteria
- not able to comply with the protocol
- with high risks which may compromise the benefit of proposed regimen
- Active (significant or uncontrolled) gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100036
Aiwen Wu, MD, 86 10 88196050, wuaw@sina.com
About this study
Official title: Neoadjuvant Chemotherapy With Xeloda in Combination With Paclitaxel in Gastric Cancer With Liver Metastasis
To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant chemotherapy for gastric cancer with liver metastasis only
Read the detailed description
Patients with advanced or metastatic gastric cancer have a poor prognosis. The optimal treatment of gastric cancer with liver metastases without other distant metastases remains a matter for debate and there are few prospective clinical trials to explore this area. The aim of this prospective phase II study is to evaluate the optimal treatment of gastric cancer with liver metastases.
In preclinical xenograft models, capecitabine was highly active against several tumors, including breast, colorectal, gastric, and cervical tumors, and against both 5-FU-sensitive and 5-FU-resistant tumors. Intermittent capecitabine (1250 mg/m2 daily dose for 14 days, followed by a 7-day rest period) was shown to be active as a single agent in previously untreated AGC patients, with a response rate of 28.2% in 39 patients. The combination of capecitabine with other drugs, such as cisplatin, oxaliplatin, epirubicin, and docetaxel, had an objective response rate of 40-68% as first-line treatment in patients with AGC.
In human colon cancer xenograft model, thymidine phosphorylase is upregulated and synergy between paclitaxel and capecitabine has been observed. The activity of capecitabine in patients with breast cancer refractory to paclitaxel and anthracyclines suggests that the combination of capecitabine and paclitaxel may be effective in treating patients with advanced breast cancer. Doses recommended are capecitabine 1650 mg/m2 per day orally for 14 days and paclitaxel 175 mg/m2 i.v. every 3 weeks.
In a phase II trial with 45 patients involved, 2 patients showed complete response and 20 showed partial response making the overall response rate 48.9% (95%CI:30.3-63.5%). There was no neutropaenic fever or treatment-related deaths. That study demonstrated that paclitaxel and capecitabine combination chemotherapy was active and highly tolerable.
The rationale of this study was to find out if outcome could be improved after neoadjuvant chemotherapy with paclitaxel and capecitabine with or without local treatment for patients without other distant metastasis than liver metastasis.
- Conditions
- Gastric Cancer
- Being tested
- CAPECITABINE
- Keywords
- gastric cancer with liver metastasis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPECITABINEDrug
Also called Xeloda
Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; Repeat three cycles (approximately 3- months);
| Study group | Role | What they receive |
|---|---|---|
| CAPECITABINE | Experimental | Single arm:
Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; repeat three cycles (approximately 3- months); Receives: Drug: CAPECITABINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided
Primary Endpoint is PFS (progression free survival), tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided.
Measured: 3 years from last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Jiafu Ji, Post-Doctor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167049
- Sponsor's protocol ID
- ML22199
- Status last verified
- Jul 2010
- First submitted
- 21 Jul 2010
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy With Xeloda in Combination With Paclitaxel in Gastric Cancer With Liver Metastasis
- ClinicalTrials.gov ID
- NCT01167049
- Acronym / sponsor ID
- ML22199
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer with liver metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Aug 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Jul 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.
To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant chemotherapy for gastric cancer with liver metastasis only
Detailed description
Patients with advanced or metastatic gastric cancer have a poor prognosis. The optimal treatment of gastric cancer with liver metastases without other distant metastases remains a matter for debate and there are few prospective clinical trials to explore this area. The aim of this prospective phase II study is to evaluate the optimal treatment of gastric cancer with liver metastases.
In preclinical xenograft models, capecitabine was highly active against several tumors, including breast, colorectal, gastric, and cervical tumors, and against both 5-FU-sensitive and 5-FU-resistant tumors. Intermittent capecitabine (1250 mg/m2 daily dose for 14 days, followed by a 7-day rest period) was shown to be active as a single agent in previously untreated AGC patients, with a response rate of 28.2% in 39 patients. The combination of capecitabine with other drugs, such as cisplatin, oxaliplatin, epirubicin, and docetaxel, had an objective response rate of 40-68% as first-line treatment in patients with AGC.
In human colon cancer xenograft model, thymidine phosphorylase is upregulated and synergy between paclitaxel and capecitabine has been observed. The activity of capecitabine in patients with breast cancer refractory to paclitaxel and anthracyclines suggests that the combination of capecitabine and paclitaxel may be effective in treating patients with advanced breast cancer. Doses recommended are capecitabine 1650 mg/m2 per day orally for 14 days and paclitaxel 175 mg/m2 i.v. every 3 weeks.
In a phase II trial with 45 patients involved, 2 patients showed complete response and 20 showed partial response making the overall response rate 48.9% (95%CI:30.3-63.5%). There was no neutropaenic fever or treatment-related deaths. That study demonstrated that paclitaxel and capecitabine combination chemotherapy was active and highly tolerable.
The rationale of this study was to find out if outcome could be improved after neoadjuvant chemotherapy with paclitaxel and capecitabine with or without local treatment for patients without other distant metastasis than liver metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAPECITABINE | Experimental | Drug: CAPECITABINESingle arm: Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; repeat three cycles (approximately 3- months); |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ambulatory males or females, aged no less than 18 years.
- ECOG performance status: 0-1.
- Histologically confirmed gastric adeno-carcinoma.
- Radiologically confirmed liver metastasis without other distant metastasis.
- No serious concomitant medical illnesses
Key exclusion criteria (4 listed)
- not fit for the inclusion criteria
- not able to comply with the protocol
- with high risks which may compromise the benefit of proposed regimen
- Active (significant or uncontrolled) gastrointestinal bleeding
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 |
|---|---|---|
| CAPECITABINEAlso: XelodaCapecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; Repeat three cycles (approximately 3- months); | Drug | CAPECITABINE |
Primary outcome
Tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided
Time frame: 3 years from last patient enrolled
Primary Endpoint is PFS (progression free survival), tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
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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.
Jiafu Ji, Post-Doctor principal investigator
Peking University Cancer Hospital & Institute
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 in people with Gastric Cancer, run by Peking University Cancer Hospital & Institute 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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2010. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiafu Ji, Post-Doctor (86 21 88196048, jiafuj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided (time frame: 3 years from last patient enrolled). 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 22 Jul 2010.