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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04034251.
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.
Lead OrganizationNational Cancer Institute
Principal InvestigatorJeremy L Davis