Gastric AdenocarcinomaPhase 2NCT04034251
Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis
A Phase 2 study testing Paclitaxel, Capecitabine and BardPort Titanium Implanted Port with Peritoneal Catheter in people with Gastric Adenocarcinoma and Gastric Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow. Objective: To find a better way to treat advanced stomach cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastric Cancer, Esophagogastric Junction
- What is being tested?
- Paclitaxel, Capecitabine and BardPort Titanium Implanted Port with Peritoneal Catheter
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2020to 5 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Patients who are receiving any other investigational agents.
- Previous cytoreductive surgery or intraperitoneal chemotherapy.
- Disseminated extra-peritoneal or solid organ metastases:
- Excludes greater omentum and ovarian metastases.
- Radiographic signs or clinical symptoms consistent with malignant bowel obstruction.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Paclitaxel or Capecitabine or other agents used in study.
Show all 11Show fewer
- Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of disease.
- Existing peripheral neuropathy, Grade 3 or greater.
- Past medical history of dihydropyrimidine dehydrogenase deficiency.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded because paclitaxel and capecitabine can cause fetal harm when administered to pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel and capecitabine, breastfeeding should be discontinued if the mother is treated with paclitaxel and capecitabine.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis
Background:
Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow.
Read more
Objective:
To find a better way to treat advanced stomach cancer.
Eligibility:
People ages 18 and older with stomach cancer that has spread throughout their belly.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Scans
Cancer sample: If they do not have one, they will have a biopsy.
Tests of performance of normal activities
Dietary assessment
Participants will have a laparoscopy. Small cuts are made into their abdomen. A thin camera with a light is inserted. Small instruments are used to take biopsies. This will be repeated during the study to monitor the cancer. During the first laparoscopy, a port with a catheter attached will be put into the abdomen.
Participants may also have an endoscopy: A thin tube with a camera is inserted through the mouth and into the stomach. The tube collects samples to monitor the cancer.
Participants will get paclitaxel every 3 weeks through the abdominal port and through a small plastic tube in an arm vein. They will also take capecitabine by mouth twice daily for the first 15 days of a 21-day cycle.
After participants finish 3 cycles, they will have scans to see how they are doing. They may get another course of therapy.
Participants will have visits every 3 weeks during treatment. Then they will have follow-up visits for 5 years. Then they will keep in touch with researchers for the rest of their life.
Read the detailed description
Background:
- An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the United States (U.S.)
- Peritoneal metastasis is a common finding at diagnosis, making curative surgical resection possible in an estimated 25% of patients.
- Systemic chemotherapy is the recommended treatment for patients with metastatic gastric cancer to the peritoneal cavity, however selective use of cytoreductive surgery and intraperitoneal chemotherapy has been associated with improved overall survival.
- Multiple chemotherapeutic agents and delivery systems have been described for intraperitoneal therapy, but no standard regimen exists.
Objective:
-Determine the intraperitoneal progression free survival (iPFS) in patients with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy.
Eligibility:
- Histologically confirmed adenocarcinoma of the stomach.
- Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of peritoneal carcinomatosis found at staging laparoscopy.
- Medically fit for systemic chemotherapy and intraperitoneal chemotherapy.
- Men and women age greater than or equal to 18 years.
Design:
- Phase II, nonrandomized, open label study.
- Patients will enroll in two cohorts: those with prior systemic chemotherapy and those who are treatment naive.
- Patients undergo staging laparoscopy and placement of peritoneal access port.
- Intraperitoneal paclitaxel (60 mg/m^2 weekly), intravenous paclitaxel (80 mg/m^2 weekly), and capecitabine (825 mg/m^2 twice daily for 14 days of each cycle) for 12 weeks.
- Treatment response will be assessed with imaging and laparoscopy.
- It is expected that 16-20 patients per year for total 4 years will be enrolled. The accrual ceiling is set at 74 patients.
- Conditions
- Gastric Adenocarcinoma, Gastric Cancer, Esophagogastric Junction, Peritoneal Carcinomatosis
- Being tested
- Paclitaxel, Capecitabine, BardPort Titanium Implanted Port with Peritoneal Catheter
- Keywords
- Gastroesophageal Junction (Siewert III) Adenocarcinoma, Intravenous Chemotherapy, Progression Free Survival, Peritoneal Metastasis, Intraperitoneal Chemotherapy
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Paclitaxel (intraperitoneal (IP) and intravenous (IV), Day 1 of each 3-week cycle: Paclitaxel IP - Intraperitoneal paclitaxel (60 mg/m^2) will be diluted in 500 mL of 0.9% normal saline (NS), to be infused as rapidly as tolerated once per 3-week cycle on Day 1. Paclitaxel IV - Intravenous paclitaxel (80 mg/m^2) will be administered concomitantly over 3 hours, diluted in 100 to 250 ml of 0.9% NS once per 3-week cycle on Day 1.
CapecitabineDrug
Also called Xeloda
Day 1-15 of each 3-week cycle: oral capecitabine (825 mg/m^2) to be taken twice a day starting the evening of Day 1 of each cycle until the morning of Day 15, followed by a 7-day rest period during each 3-week cycle.
BardPort Titanium Implanted Port with Peritoneal CatheterDevice
After peritoneal chemo infusion port is placed (Days 1-3, as dictated by clinical status), patients will begin intraperitoneal paclitaxel and intravenous paclitaxel (Day 1) followed by oral capecitabine on the evening of Day 1 to the morning of Day 15.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | Experimental | Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine Receives: Drug: Paclitaxel; Drug: Capecitabine; Device: BardPort Titanium Implanted Port with Peritoneal Catheter |
| Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | Experimental | Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine Receives: Drug: Paclitaxel; Drug: Capecitabine; Device: BardPort Titanium Implanted Port with Peritoneal Catheter |
| Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily | Experimental | Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine Receives: Drug: Paclitaxel; Drug: Capecitabine; Device: BardPort Titanium Implanted Port with Peritoneal Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy
PFS is the amount of time a participant survives without progression of disease after treatment with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI, new ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes.
Measured: From the first treatment to progression of disease, up to 2 years and 1 month
Secondary outcomes (7)
Overall Survival (OS)
OS is the median amount of time a participant survives after treatment.
Measured: From first treatment until death, an average of 1.5 years
Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions
Serious and/or non-serious adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death.
Measured: Date treatment consent signed to date off study, 18 months and 8 days; and 25 months and 10 days for the first and second group, respectively.
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval
iPFS is the median amount of time a participant survives without intra-peritoneal disease progression reported with an 80% confidence interval. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes.
Measured: From the first treatment to progression of disease, up to 2 years and 1 month
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval
Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes.
Measured: From the first treatment to progression of disease, up to 2 years and 1 month
Frequency of Objective Histopathologic Response to Therapy
Participants metastatic tumors are biopsied at the end of a course of therapy and graded according to standard pathologic technique.
Measured: At end of each course (3 treatment cycles; 9 weeks)
Number of Participants With Distant Extra-peritoneal Disease-free Survival
dDFS was determined based on identification of only distant sites of disease progression, such as lungs or intra-parenchymal liver. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes.
Measured: From start of treatment to until time of extra-peritoneal progression, an average of 1 year
Number of Participants With Intra-peritoneal Progression Free Survival (iPFS)
iPFS was determined based on identification of only intraperitoneal sites such as new, malignant ascites, peritoneal nodules, or ovarian metastases. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI. New ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes.
Measured: At extra-peritoneal progression, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start9 Jun 2020
- Primary completion25 Feb 2023
- Study completion5 Sep 2024
Why it stopped: Scientific reprioritization. Closed per principal investigator discretion to prioritize enrollment in another study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Andrew Blakely, National Cancer Institute (NCI)
- Investigators
- Andrew Blakely, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034251
- Sponsor's protocol ID
- 190129
- Other IDs
- 19-C-0129
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2019
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT04034251
- Acronym / sponsor ID
- 190129
- Conditions
- Gastric Adenocarcinoma, Gastric Cancer, Esophagogastric Junction, Peritoneal Carcinomatosis
- Keywords
- Gastroesophageal Junction (Siewert III) Adenocarcinoma, Intravenous Chemotherapy, Progression Free Survival, Peritoneal Metastasis, Intraperitoneal Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Scientific reprioritization. Closed per principal investigator discretion to prioritize enrollment in another study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Posted 12 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow.
Objective:
To find a better way to treat advanced stomach cancer.
Eligibility:
People ages 18 and older with stomach cancer that has spread throughout their belly.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Scans
Cancer sample: If they do not have one, they will have a biopsy.
Tests of performance of normal activities
Dietary assessment
Participants will have a laparoscopy. Small cuts are made into their abdomen. A thin camera with a light is inserted. Small instruments are used to take biopsies. This will be repeated during the study to monitor the cancer. During the first laparoscopy, a port with a catheter attached will be put into the abdomen.
Participants may also have an endoscopy: A thin tube with a camera is inserted through the mouth and into the stomach. The tube collects samples to monitor the cancer.
Participants will get paclitaxel every 3 weeks through the abdominal port and through a small plastic tube in an arm vein. They will also take capecitabine by mouth twice daily for the first 15 days of a 21-day cycle.
After participants finish 3 cycles, they will have scans to see how they are doing. They may get another course of therapy.
Participants will have visits every 3 weeks during treatment. Then they will have follow-up visits for 5 years. Then they will keep in touch with researchers for the rest of their life.
Detailed description
Background:
- An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the United States (U.S.)
- Peritoneal metastasis is a common finding at diagnosis, making curative surgical resection possible in an estimated 25% of patients.
- Systemic chemotherapy is the recommended treatment for patients with metastatic gastric cancer to the peritoneal cavity, however selective use of cytoreductive surgery and intraperitoneal chemotherapy has been associated with improved overall survival.
- Multiple chemotherapeutic agents and delivery systems have been described for intraperitoneal therapy, but no standard regimen exists.
Objective:
-Determine the intraperitoneal progression free survival (iPFS) in patients with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy.
Eligibility:
- Histologically confirmed adenocarcinoma of the stomach.
- Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of peritoneal carcinomatosis found at staging laparoscopy.
- Medically fit for systemic chemotherapy and intraperitoneal chemotherapy.
- Men and women age greater than or equal to 18 years.
Design:
- Phase II, nonrandomized, open label study.
- Patients will enroll in two cohorts: those with prior systemic chemotherapy and those who are treatment naive.
- Patients undergo staging laparoscopy and placement of peritoneal access port.
- Intraperitoneal paclitaxel (60 mg/m^2 weekly), intravenous paclitaxel (80 mg/m^2 weekly), and capecitabine (825 mg/m^2 twice daily for 14 days of each cycle) for 12 weeks.
- Treatment response will be assessed with imaging and laparoscopy.
- It is expected that 16-20 patients per year for total 4 years will be enrolled. The accrual ceiling is set at 74 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily | Experimental | Drug: Paclitaxel, Drug: Capecitabine, Device: BardPort Titanium Implanted Port with Peritoneal CatheterIntraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine |
| Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily | Experimental | Drug: Paclitaxel, Drug: Capecitabine, Device: BardPort Titanium Implanted Port with Peritoneal CatheterIntraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine |
| Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily | Experimental | Drug: Paclitaxel, Drug: Capecitabine, Device: BardPort Titanium Implanted Port with Peritoneal CatheterIntraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Patients who are receiving any other investigational agents.
- Previous cytoreductive surgery or intraperitoneal chemotherapy.
- Disseminated extra-peritoneal or solid organ metastases:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Paclitaxel or Capecitabine or other agents used in study.
- Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of disease.
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: TaxolPaclitaxel (intraperitoneal (IP) and intravenous (IV), Day 1 of each 3-week cycle: Paclitaxel IP - Intraperitoneal paclitaxel (60 mg/m^2) will be diluted in 500 mL of 0.9% normal saline (NS), to be infused as rapidly as tolerated once per 3-week cycle on Day 1. Paclitaxel IV - Intravenous paclitaxel (80 mg/m^2) will be administered concomitantly over 3 hours, diluted in 100 to 250 ml of 0.9% NS once per 3-week cycle on Day 1. | Drug | Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily, Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily, Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily |
| CapecitabineAlso: XelodaDay 1-15 of each 3-week cycle: oral capecitabine (825 mg/m^2) to be taken twice a day starting the evening of Day 1 of each cycle until the morning of Day 15, followed by a 7-day rest period during each 3-week cycle. | Drug | Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily, Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily, Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily |
| BardPort Titanium Implanted Port with Peritoneal CatheterAfter peritoneal chemo infusion port is placed (Days 1-3, as dictated by clinical status), patients will begin intraperitoneal paclitaxel and intravenous paclitaxel (Day 1) followed by oral capecitabine on the evening of Day 1 to the morning of Day 15. | Device | Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily, Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily, Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily |
Primary outcome
Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy
Time frame: From the first treatment to progression of disease, up to 2 years and 1 month
PFS is the amount of time a participant survives without progression of disease after treatment with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI, new ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes.
7 secondary outcomes
Overall Survival (OS)
Time frame: From first treatment until death, an average of 1.5 years
Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions
Time frame: Date treatment consent signed to date off study, 18 months and 8 days; and 25 months and 10 days for the first and second group, respectively.
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval
Time frame: From the first treatment to progression of disease, up to 2 years and 1 month
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval
Time frame: From the first treatment to progression of disease, up to 2 years and 1 month
Frequency of Objective Histopathologic Response to Therapy
Time frame: At end of each course (3 treatment cycles; 9 weeks)
Number of Participants With Distant Extra-peritoneal Disease-free Survival
Time frame: From start of treatment to until time of extra-peritoneal progression, an average of 1 year
Number of Participants With Intra-peritoneal Progression Free Survival (iPFS)
Time frame: At extra-peritoneal progression, an average of 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
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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.
Andrew Blakely, M.D. principal investigator
National Cancer Institute (NCI)
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 Paclitaxel, Capecitabine and BardPort Titanium Implanted Port with Peritoneal Catheter in people with Gastric Adenocarcinoma and Gastric Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 0 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 May 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy (time frame: From the first treatment to progression of disease, up to 2 years and 1 month). 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 5 May 2026.