Stage IV Gastric Cancer With MetastasisPhase 1/2XPIDNCT01525771
Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer
A Phase 1/2 study testing Docetaxel in people with Stage IV Gastric Cancer With Metastasis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Gastric Cancer With Metastasis
- What is being tested?
- Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to Dec 2014
- Phase
- Phase 1/2
- 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
- Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
- Peritoneal seeding proven by histology or cytology
- Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded)
- Age 18 to 70 years old
- Eastern Cooperative Oncology Group performance status <_ 2
- Estimated life expectancy of more than 3 months
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- Adequate bone marrow function (WBCs>3,000/µL and absolute neutrophil count (ANC) >1,500/µL and platelets>100,000/µL),
- Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance _> 60ml/min
- Adequate hepatic function: bilirubin < 1.5 x UNL, AST/ALT levels < 2.5 x UNL, alkaline phosphatase < 5 x UNL (except in case of bone metastasis without any liver disease)
- Written informed consent
Who cannot join
- Contraindication to any drug contained in the chemotherapy regimen
- Other tumor type than adenocarcinoma
- Presence or history of CNS metastasis
- Gastric outlet or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy > grade 2
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- History of significant neurologic or psychiatric disorders
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding
A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.
Read the detailed description
Single-center, open-label, prospective, single-arm, phase I-II study
About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Being tested
- Docetaxel
- Keywords
- Advanced Gastric cancer, Xeloda (Capecitabine), Cisplatin, Taxotere (Docetaxel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelOther
Also called XP with Intraperitoneal Docetaxel, Capecitabine, Cisplatin
The study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients.
- Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100)
- Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days
- Cisplatin 60mg/m2 IV (D1) every 21 days
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Single-center, open-label, prospective, single-arm, phase I-II study Receives: Other: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Phase I Study
- Maximum tolerated dose of Intraperitoneal Docetaxel
Phase II Study
- Progression-free survival rate at 6 months
- response rate, time to progression, overall survival
Measured: 1 year
Secondary outcomes (4)
Safety profile
Measured: 1 year
Overall survival
Measured: 1 year
Progression free survival
Measured: 1 year
efficacy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Gastric Cancer With MetastasisStudies of the same condition, open and under way.
- More trials run by Asan 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Hee Ryu, Asan Medical Center
- Investigators
- Min-Hee Ryu, MD, Principal investigator, Asan Medical Center/Univ of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525771
- Sponsor's protocol ID
- AMC-XPID-1
- Acronym
- XPID
- Status last verified
- Jun 2015
- First submitted
- 18 Jul 2011
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding
- ClinicalTrials.gov ID
- NCT01525771
- Acronym / sponsor ID
- XPID / AMC-XPID-1
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Keywords
- Advanced Gastric cancer, Xeloda (Capecitabine), Cisplatin, Taxotere (Docetaxel)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Feb 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.
A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.
Detailed description
Single-center, open-label, prospective, single-arm, phase I-II study
About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | Other: DocetaxelSingle-center, open-label, prospective, single-arm, phase I-II study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
- Peritoneal seeding proven by histology or cytology
- Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded)
- Age 18 to 70 years old
- Eastern Cooperative Oncology Group performance status <_ 2
Key exclusion criteria (10 listed)
- Contraindication to any drug contained in the chemotherapy regimen
- Other tumor type than adenocarcinoma
- Presence or history of CNS metastasis
- Gastric outlet or bowel obstruction
- Evidence of serious 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 |
|---|---|---|
| DocetaxelAlso: XP with Intraperitoneal Docetaxel, Capecitabine, CisplatinThe study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients. * Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100) * Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days * Cisplatin 60mg/m2 IV (D1) every 21 days | Other | No intervention |
Primary outcome
Maximum tolerated dose
Time frame: 1 year
Phase I Study - Maximum tolerated dose of Intraperitoneal Docetaxel Phase II Study * Progression-free survival rate at 6 months * response rate, time to progression, overall survival
4 secondary outcomes
Safety profile
Time frame: 1 year
Overall survival
Time frame: 1 year
Progression free survival
Time frame: 1 year
efficacy
Time frame: 1 year
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 29 Jun 2015.
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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.
Min-Hee Ryu, MD principal investigator
Asan Medical Center/Univ of Ulsan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel in people with Stage IV Gastric Cancer With Metastasis, run by Asan 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 10 inclusion and 10 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 29 Jun 2015. 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 combined 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.
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?
Maximum tolerated dose (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 29 Jun 2015.