Gastric AdenocarcinomaPhase 2NCT01641783
Efficacy and Safety Study of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients
A Phase 2 study testing nanoparticle Albumin-Bound paclitaxel in people with Gastric Adenocarcinoma, run by Yanqiao Zhang.
Trial summary
Gastric cancer remains one of the major causes of cancer deaths around the world,especially in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still poor, so the investigators urgently need an effective strategy to treat advanced gastric cancer, however, there was no recommended… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- nanoparticle Albumin-Bound paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent form;
- histologically or cytologically confirmed gastric cancer;
- Age 18-75 years;
- Advanced or recurrent, metastatic disease;
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
- Life expectancy of at least 12 weeks;
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- At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors );
- no prior history of chemotherapy or beyond 6 months after the end of systemic adjuvant treatment;
- Haematopoietic status:
- Absolute neutrophil count > 1.5 x 109/L;
- Platelet count > 90 x 109/L;
- Hemoglobin at least 90g/l;
- Hepatic status:
- Bilirubin ≤ 1.5 x upper limit of normal (ULN);
- AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤ 5 times ULN (with liver metastasis);
- ALP ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver or bone metastasis);
- serum albumin ≥ 30g/L;
- Renal status:
- Creatinine ≤ 1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥ 40 mL/min;
- Able to swallow and retain oral medication;
Who cannot join
- peripheral neuropathy of grade 2 or greater;
- symptomatic brain metastasis;
- known history of uncontrolled or symptomatic angina;
- clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;
- dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
- active or uncontrolled infection;
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- pregnant or lactating women;
- dysmetabolism with nanoparticle Albumin-bound paclitaxel or Capecitabine
- unable to swallow and retain oral medication,intestinal Obstruction,alimentary tract hemorrhage
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Evaluate the Efficacy and Safety of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients:a Phase II Single Center Prospective Clinical Trial
Gastric cancer remains one of the major causes of cancer deaths around the world,especially in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still poor, so the investigators urgently need an effective strategy to treat advanced gastric cancer, however, there was no recommended First-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab) Paclitaxel (Abraxane，ABI-007) with high effectiveness and low toxicity had been approved in breast cancer as first-line chemotherapy in many countries. The investigator then initiated a prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer to observe the efficacy and safety.
Read the detailed description
A single arm,open,phase II study of Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer.
Nab-Paclitaxel should be given intravenously on days 1 and 8 at a dose as follows. Treatment should be repeated every 3 weeks:Nab-Paclitaxel:125 mg/m2; Capecitabine should be given orally twice a day as follows for 14 consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. Capecitabine:1000mg/m2,twice daily (bid).
If applicable,the value of response and prognosis predictive factors are expected to be identified.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- nanoparticle Albumin-Bound paclitaxel
- Keywords
- advanced, paclitaxel, capecitabine, first line therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoparticle Albumin-Bound paclitaxelDrug
Also called ABI-007
nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv
| Study group | Role | What they receive |
|---|---|---|
| nanoparticle Albumin-bound paclitaxel | Experimental | evaluate one dose level of nab-paclitaxel:125mg/m2 Receives: Drug: nanoparticle Albumin-Bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
the follow-up visit of PFS will be performed every 6 weeks
Measured: 1 year
Secondary outcomes (3)
objective response rate
CT/MRI/Ultrasound will be performed every 2 cycles of treatment for efficacy evaluation
Measured: 6 weeks
overall survival of participants
OS means that from the first dose of treatment drug to death or lost,the follow-up visit will be performed every 3 months till death or lost
Measured: 2 years
biomarkers
To identify the molecular biomarkers(such as SPARK,β-Tubulin III,caveolin,etc)by immunohistochemical and western-bloting before and during therapy,to study the biomarkers correlations with clinical outcome and toxicity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- 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 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqiao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqiao Zhang, The Third Affiliated Hospital of Harbin Medical University
- Investigators
- Yanqiao Zhang, M.D., Principal investigator, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641783
- Sponsor's protocol ID
- YL2012-03
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients:a Phase II Single Center Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01641783
- Acronym / sponsor ID
- YL2012-03
- Conditions
- Gastric Adenocarcinoma
- Keywords
- advanced, paclitaxel, capecitabine, first line therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yanqiao ZhangUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Jul 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.
Gastric cancer remains one of the major causes of cancer deaths around the world,especially in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still poor, so the investigators urgently need an effective strategy to treat advanced gastric cancer, however, there was no recommended First-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab) Paclitaxel (Abraxane，ABI-007) with high effectiveness and low toxicity had been approved in breast cancer as first-line chemotherapy in many countries. The investigator then initiated a prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer to observe the efficacy and safety.
Detailed description
A single arm,open,phase II study of Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer.
Nab-Paclitaxel should be given intravenously on days 1 and 8 at a dose as follows. Treatment should be repeated every 3 weeks:Nab-Paclitaxel:125 mg/m2; Capecitabine should be given orally twice a day as follows for 14 consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. Capecitabine:1000mg/m2,twice daily (bid).
If applicable,the value of response and prognosis predictive factors are expected to be identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nanoparticle Albumin-bound paclitaxel | Experimental | Drug: nanoparticle Albumin-Bound paclitaxelevaluate one dose level of nab-paclitaxel:125mg/m2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- signed informed consent form;
- histologically or cytologically confirmed gastric cancer;
- Age 18-75 years;
- Advanced or recurrent, metastatic disease;
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
Key exclusion criteria (9 listed)
- peripheral neuropathy of grade 2 or greater;
- symptomatic brain metastasis;
- known history of uncontrolled or symptomatic angina;
- clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;
- dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
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 |
|---|---|---|
| nanoparticle Albumin-Bound paclitaxelAlso: ABI-007nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv | Drug | nanoparticle Albumin-bound paclitaxel |
Primary outcome
progression free survival
Time frame: 1 year
the follow-up visit of PFS will be performed every 6 weeks
3 secondary outcomes
objective response rate
Time frame: 6 weeks
overall survival of participants
Time frame: 2 years
biomarkers
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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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.
Yanqiao Zhang, M.D. principal investigator
Harbin Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nanoparticle Albumin-Bound paclitaxel in people with Gastric Adenocarcinoma, run by Yanqiao Zhang.
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 20 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: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 Yanqiao Zhang, M.D. (86-0451-86298222, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 1 year). 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 17 Jul 2012.