Neoplasms

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Digestive System Diseases

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Adenocarcinoma

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Neoplasm Metastasis

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Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Abdominal Neoplasms

Peritoneal Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Capecitabine

Tubulin Modulators

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Antimetabolites

Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine

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.

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.

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.

BardPort Titanium Implanted Port with Peritoneal Catheter

Jeremy L Davis, M.D.

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.

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.

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

A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

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).

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.

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.

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

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.

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.

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.

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

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.

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.

National Cancer Institute (NCI)

Principal Investigator

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

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 20mg & 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 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Collected baseline data are reported for one participant in the first group who was later deemed ineligible.

Dr. Jeremy L. Davis

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

Overall Survival (OS)

Serious Adverse Events Grade 3

Serious Adverse Events Grade 4

Serious Adverse Events Grade 5

Non-Serious Adverse Events Grade 3

Non-Serious Adverse Events Grade 4

Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions

Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval

Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval

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

Frequency of Objective Histopathologic Response to Therapy

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.

Number of Participants With Distant Extra-peritoneal Disease-free Survival

Number of Participants With Intra-peritoneal Progression Free Survival (iPFS)

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis	NCT04034251	Gastric Adenoca... Gastric Cancer Esophagogastric... Peritoneal Carc...	Paclitaxel Capecitabine BardPort Titani...	18 Years -	National Institutes of Health Clinical Center (CC)
Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis	NCT04034251	Gastric Adenoca... Gastric Cancer Esophagogastric... Peritoneal Carc...	Paclitaxel Capecitabine BardPort Titani...	18 Years -	National Institutes of Health Clinical Center (CC)

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