Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis
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|ClinicalTrials.gov Identifier: NCT04034251|
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : September 22, 2020
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.
To find a better way to treat advanced stomach cancer.
People ages 18 and older with stomach cancer that has spread throughout their belly.
Participants will be screened with:
Blood, urine, and heart tests
Cancer sample: If they do not have one, they will have a biopsy.
Tests of performance of normal activities
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Gastric Cancer Esophagogastric Junction Peritoneal Carcinomatosis||Drug: Paclitaxel Drug: Capecitabine Device: BardPort Titanium Implanted Port withPeritoneal Catheter||Phase 2|
- An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the 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.
-Determine the progression free survival (PFS) in patients with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy.
- 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 agegreater than or equal to 18 years.
- Phase II, nonrandomized, open label study.
- Patients will enroll in two cohorts: those with prior systemic chemotherapy and those who are treatment naive.
- Patients will undergo staging laparoscopy and placement of peritoneal access port.
- Intraperitoneal paclitaxel (20 mg/m2 weekly), intravenous paclitaxel (80 mg/m2 weekly), and capecitabine (825 mg/m2 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 70 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis|
|Actual Study Start Date :||June 9, 2020|
|Estimated Primary Completion Date :||May 30, 2026|
|Estimated Study Completion Date :||January 30, 2027|
Experimental: 1/Arm 1
IP and IV paclitaxel administration with concomitant oral capecitabine
Paclitaxel (IP and IV), Day 1 of each 3-week cycle: Paclitaxel IP -Intraperitoneal paclitaxel (20 mg /m2) will be diluted in 500 mL of 0.9% NS, to be infused as rapidly as tolerated once per 3-week cycle on Day 1. Paclitaxel IV -Intravenous paclitaxel (80 mg/m2) 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 /m2) 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.
Device: BardPort Titanium Implanted Port withPeritoneal Catheter
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.
- to determine progression free survival (PFS) in patients with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy [ Time Frame: after 1 course (3 treatment cycles; 9 weeks) ]to determine if the response rate (median amount of time) is better than that of the response rate based on historical controls
- intra-peritoneal progression free survival (iPFS) [ Time Frame: at intra-peritoneal progression ]median amount of time subject survives without intraperitonealdisease progression
- frequency of objective histopathologic response to therapy [ Time Frame: at end of each course (3 treatment cycles; 9 weeks) ]graded tumor biopsy
- distant (extra-peritoneal) disease free survival [ Time Frame: at extra-peritoneal progression ]median amount of time subject survives without extraperitonealdisease progression
- morbidity of this treatment strategy [ Time Frame: 4 years ]frequency of complications and adverse events
- overall survival [ Time Frame: death ]median amount of time subject survives
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034251
|Contact: Cathleen E Hannah||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Jeremy L Davis, M.D.||National Cancer Institute (NCI)|