TerminatedPhase 2

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

Stopped: Scientific reprioritization. Closed per principal investigator discretion to prioritize enrollment in another study.

United States12 participantsStarted 2020-06-09

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients must have histologically or cytologically confirmed gastric adenocarcinoma, including Siewert III gastroesophageal junction adenocarcinoma, confirmed by the National Cancer Institute (NCI) Laboratory of Pathology, and have provided a block or unstained slides of primary or
✓. Patients may be treatment naive or have received systemic chemotherapy prior to enrollment:
✓. Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of peritoneal carcinomatosis found at staging laparoscopy.
✓. Age \>=18 years. Children under the age of 18 will not participate in this study as gastric cancer is rare in this population.
✓. Eastern Cooperative Oncology Group (ECOG) performance status \<=1
✓. Patients must have normal organ and marrow function as defined below:
✓. Physiologically able to undergo laparoscopy and systemic chemotherapy.
✓. Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion criteria

What they're measuring

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

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

Trial details

NCT IDNCT04034251

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-02-25

Results submitted2023-10-26

View on ClinicalTrials.gov More Gastric Adenocarcinoma trials