Stomach NeoplasmsPhase 1/2IPXELOXNCT04943653
Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis
A Phase 1/2 study testing Paclitaxel in people with Stomach Neoplasms and Paclitaxel, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stomach Neoplasms, Paclitaxel, Peritoneal Metastases
- What is being tested?
- Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2021to Dec 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria:
- ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
- pathologically proven primary gastric adenocarcinoma
- peritoneal metastasis confirmed by laparoscopy or diagnostic imaging
- written informed consent
- adequate function of important organs (within 14 days before registration) Absolute neutrophil count ≥1.5 x 10^9/L, Platelet >=100,000/mm3, Hemoglobin >=8.0g/dL, Total bilirubin <= ≤ 2.0mg/dl or ULN(Upper Limit of Normal) x 1.5, AST(aspartate aminotransferase) <=100IU/L(International Unit/Liter), ALT(alanine transaminase) <=100IU/L, Creatinine clearance ≥ 50mL/min (milliliter/minute),
- Exclusion Criteria:
- other active concomitant malignancies
- HER2(human epidermal growth factor receptor 2) positive (Immunohistochemistry 3+ or 2+ with in situ hybridization positive)
- no investigational anticancer therapy within 30 days prior to the first dose of study treatment
- recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease
- uncontrolled acute or chronic disease
- uncontrolled infection or inflammation
- uncontrolled psychiatric disorder or central neurologic disease
- not fully recovered from previous surgery
- prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months
- intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome
- fertile males and females who are unwilling to use effective contraceptive methods.
- pregnancy, breast feeding or intention to become pregnant
- interstitial pneumonia or pulmonary fibrosis
- peripheral neuropathy with functional impairment
- hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or Cremophor EL.
- concomitant therapy with any substrate or inhibitor of Cytochrome P450 2C8 or 3A4
- concomitant therapy with sorivudine or brivudine
- Dihydropyrimidine dehydrogenase (DPD) deficiency.
- current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gastric cancer center, Seoul St. Mary's Hospital
Seoul, 06591
Kabsoo Shin, 82-2-2258-6256, kabsoo.shin@catholic.ac.kr
About this study
Official title: Phase I,II Study of First Line Intraperitoneal Paclitaxel With Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis
IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis.
Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.
- Conditions
- Stomach Neoplasms, Paclitaxel, Peritoneal Metastases
- Being tested
- Paclitaxel
- Keywords
- Oxaliplatin, Capecitabine, XELOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called capecitabine, oxaliplatin
intraperitoneal paclitaxel
20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I)
recommended dose (phase II)
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal paclitaxel + XELOX | Experimental | Intraperitoneal paclitaxel Day1, Day8 + *XELOX
*XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression free survival (6-month PFS)
PFS is the time from date of first dose until the date of objective disease progression or death
Measured: 6 months after start of treatment
Secondary outcomes (4)
1-year overall survival (1-year OS)
OS is the time from date of first dose until death due to any cause
Measured: 1 year after start of treatment
Objective Response Rate (ORR)
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
Measured: 6 months after start of treatment
Conversion surgery rate
rate of conversion surgery
Measured: 6 months after start of treatment
Ascites response
negative conversion rate of peritoneal cytology
Measured: 6 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start8 Jun 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-ho Kim, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943653
- Sponsor's protocol ID
- KC20MISF0813
- Acronym
- IPXELOX
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I,II Study of First Line Intraperitoneal Paclitaxel With Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT04943653
- Acronym / sponsor ID
- IPXELOX / KC20MISF0813
- Conditions
- Stomach Neoplasms, Paclitaxel, Peritoneal Metastases
- Keywords
- Oxaliplatin, Capecitabine, XELOX
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jun 2021 (actual)
- 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.
IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis.
Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal paclitaxel + XELOX | Experimental | Drug: PaclitaxelIntraperitoneal paclitaxel Day1, Day8 + *XELOX *XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PaclitaxelAlso: capecitabine, oxaliplatinintraperitoneal paclitaxel 20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I) recommended dose (phase II) | Drug | Intraperitoneal paclitaxel + XELOX |
Primary outcome
6-month progression free survival (6-month PFS)
Time frame: 6 months after start of treatment
PFS is the time from date of first dose until the date of objective disease progression or death
4 secondary outcomes
1-year overall survival (1-year OS)
Time frame: 1 year after start of treatment
Objective Response Rate (ORR)
Time frame: 6 months after start of treatment
Conversion surgery rate
Time frame: 6 months after start of treatment
Ascites response
Time frame: 6 months after start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Stomach Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
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 Paclitaxel in people with Stomach Neoplasms and Paclitaxel, run by Seoul St. Mary's Hospital 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?
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 6 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kabsoo Shin (82-2-2258-6256, kabsoo.shin@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression free survival (6-month PFS) (time frame: 6 months after start of treatment). 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 6 Jul 2021.