Trial Outcomes & Findings for Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis (NCT NCT04034251)

Last Updated: 2025-02-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

From the first treatment to progression of disease, up to 2 years and 1 month

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Overall Study STARTED	5	7
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Cohort B: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Overall Study Screen failure due to development of solid organ mets in lung; no longer met eligibility criteria.	1	0	0

Baseline Characteristics

Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=5 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.28 years STANDARD_DEVIATION 9.79 • n=5 Participants	50.39 years STANDARD_DEVIATION 7.98 • n=7 Participants	49.51 years STANDARD_DEVIATION 8.41 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: From the first treatment to progression of disease, up to 2 years and 1 month

Population: 4/5 participants are analyzed in the first group because one participant was deemed ineligible.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
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	4.2 Months Interval 1.5 to NA = It is not estimable because there are insufficient events after the median is identified for the upper bound of the confidence interval to be computed. This is mostly a situation when there are very few participants, or virtually all events take place before the median time.	13.3 Months Interval 1.5 to 13.3

SECONDARY outcome

Timeframe: From first treatment until death, an average of 1.5 years

Population: 4/5 participants are analyzed in the first group because one participant was deemed ineligible.

OS is the median amount of time a participant survives after treatment.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Overall Survival (OS)	10.6 Months Interval 4.7 to 12.5	14.7 Months Interval 4.0 to 17.7

SECONDARY outcome

Timeframe: 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.

Population: 4/5 participants are analyzed in the first group because one participant was deemed ineligible.

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.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions Serious Adverse Events Grade 4	0 adverse events	0 adverse events
Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions Serious Adverse Events Grade 5	0 adverse events	0 adverse events
Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions Non-Serious Adverse Events Grade 4	0 adverse events	1 adverse events
Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions Serious Adverse Events Grade 3	0 adverse events	1 adverse events
Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions Non-Serious Adverse Events Grade 3	8 adverse events	7 adverse events

SECONDARY outcome

Timeframe: From the first treatment to progression of disease, up to 2 years and 1 month

Population: 4/5 participants are analyzed in the first group because one participant was deemed ineligible.

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.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval	4.2 Months Interval 1.4 to NA=It is not estimable because there are insufficient events after the median is identified for the upper bound of the confidence interval to be computed. This is mostly a situation when there are very few participants, or virtually all events take place before the median time.	13.3 Months Interval 2.1 to 13.3

SECONDARY outcome

Timeframe: From the first treatment to progression of disease, up to 2 years and 1 month

Population: 4/5 participants are analyzed in the first group because one participant was deemed ineligible.

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.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval	4.2 Months Interval 1.4 to NA = It is not estimable because there are insufficient events after the median is identified for the upper bound of the confidence interval to be computed. This is mostly a situation when there are very few participants, or virtually all events take place before the median time.	13.3 Months Interval 1.5 to 13.3

SECONDARY outcome

Timeframe: At end of each course (3 treatment cycles; 9 weeks)

Population: No data was collected. The pathologists were not able to provide an objective measure for this information due to technical reasons.

Participants metastatic tumors are biopsied at the end of a course of therapy and graded according to standard pathologic technique.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to until time of extra-peritoneal progression, an average of 1 year

Population: 4/5 participants are analyzed in the first group because one participant was deemed ineligible. This outcome measure was not reported with an 80% confidence interval as required by the protocol because only one participant ever experienced extra peritoneal progression and a median could not be calculated.

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.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Number of Participants With Distant Extra-peritoneal Disease-free Survival	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At extra-peritoneal progression, an average of 1 year

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.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Number of Participants With Intra-peritoneal Progression Free Survival (iPFS)	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Population: 4/5 participants are analyzed in the first group because one participant was deemed ineligible.

Here is the number of participants with serious and/or non-serious adverse events 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.

Outcome measures

Outcome measures
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 Participants Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	4 Participants	7 Participants

Adverse Events

Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily

Serious events: 1 serious events

Other events: 7 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily n=4 participants at risk Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (20 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.	Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily n=7 participants at risk Intraperitoneal and intravenous paclitaxel administration with concomitant oral capecitabine. Intraperitoneal Paclitaxel (60 mg/m\^2) every 3 weeks (Q3WK), intravenous Paclitaxel (80 mg/m\^2) Q3WK, Capecitabine (825mg/m\^2 twice daily (BID) x 14 days of each cycle). Cohort A: Participants with confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (Siewert III) adenocarcinoma who have received prior systemic chemotherapy.
Infections and infestations Abdominal infection	0.00% 0/4 • 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. 4/5 participants are analyzed in the first group because one participant was deemed ineligible.	14.3% 1/7 • Number of events 1 • 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. 4/5 participants are analyzed in the first group because one participant was deemed ineligible.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • 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. 4/5 participants are analyzed in the first group because one participant was deemed ineligible.	0.00% 0/7 • 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. 4/5 participants are analyzed in the first group because one participant was deemed ineligible.

Other adverse events

Additional Information

Dr. Andrew Blakely

National Cancer Institute

Phone: 240-760-7647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place