Gastric CarcinomaPhase 1NCT00639522
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
A Phase 1 study testing Liposomal paclitaxel and capecitabine in people with Gastric Carcinoma, run by Nanjing Sike Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- Liposomal paclitaxel and capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Dec 2009
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;
- No prior systemic chemotherapy with taxane at least 6 months before the recruitment;
- At least one measurable tumor according to RECIST standard, with at least one diameter ≥20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Patients who are expected to live at least 3 months;
- Obtaining informed consent;
Who cannot join
- Receiving other chemotherapy or radiotherapy during the administration;
- Symptomatic metastatic brain tumor;
- Allergy to any study medication;
- Pregnancy or breast feeding;
- Severe heart diseases;
- Uncontrolled mental diseases;
- Abnormal liver and renal functions, which are measured by AST/ALT and BUN/Cr;
- Neutrophils（ANC）<2000/μL;platelets<100，000/μL;hemoglobin（HB）<9.0 g/dL;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Jinwan Wang, Doctor, 086-010-87788842, hsunyk@tom.com
Chi Yihebali, Doctor, 086-010-87788118, yihebalichi@yahoo.com.cn
About this study
Official title: A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.
The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.
Read the detailed description
The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.
- Conditions
- Gastric Carcinoma
- Being tested
- Liposomal paclitaxel and capecitabine
- Keywords
- Liposomal paclitaxel, Maximum tolerated dose, Pharmacokinetics, Gastric carcinoma
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal paclitaxel and capecitabineDrug
Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Liposomal paclitaxel and capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Measured: 6 weeks
Secondary outcomes (1)
Pharmacokinetics
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sike Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jinwan Wang, Doctor, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639522
- Sponsor's protocol ID
- LPS-GC-01-2008
- Status last verified
- Apr 2009
- First submitted
- 14 Mar 2008
- Last updated
- 15 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.
- ClinicalTrials.gov ID
- NCT00639522
- Acronym / sponsor ID
- LPS-GC-01-2008
- Conditions
- Gastric Carcinoma
- Keywords
- Liposomal paclitaxel, Maximum tolerated dose, Pharmacokinetics, Gastric carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Nanjing Sike Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 20 Mar 2008 (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 investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.
Detailed description
The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Liposomal paclitaxel and capecitabine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;
- No prior systemic chemotherapy with taxane at least 6 months before the recruitment;
- At least one measurable tumor according to RECIST standard, with at least one diameter ≥20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Patients who are expected to live at least 3 months;
- Obtaining informed consent;
Key exclusion criteria (8 listed)
- Receiving other chemotherapy or radiotherapy during the administration;
- Symptomatic metastatic brain tumor;
- Allergy to any study medication;
- Pregnancy or breast feeding;
- Severe heart diseases;
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 |
|---|---|---|
| Liposomal paclitaxel and capecitabinePatients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2、185mg/m2、195mg/m2、 200mg/m2、205mg/m2 and so on ,at the first day of chemotherapy. Capecitabine will be given on d1 to d14 with the dose of 185mg/m2、200mg/m2 or d8 to d21 with the dose of 175mg/m2、195mg/m2、205mg/m2 .Cycle duration will be 21 days. Each patient will receive 2 cycles of therapy. Only in the first cycle blood samples will be taken on 16 points in 48 hours after the infusion of liposomal paclitaxel. | Drug | A |
Primary outcome
Dose limiting toxicity
Time frame: 6 weeks
1 secondary outcome
Pharmacokinetics
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2009.
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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.
Jinwan Wang, Doctor principal investigator
Cancer Hospital Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal paclitaxel and capecitabine in people with Gastric Carcinoma, run by Nanjing Sike Pharmaceutical Co., Ltd. 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 5 inclusion and 8 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 15 Apr 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jinwan Wang, Doctor (086-010-87788842, hsunyk@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: 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 15 Apr 2009.