Clinical trial: Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis (NCT04034251)

Eligibility criteria:
-INCLUSION CRITERIA:

          1. Patients must have histologically or cytologically confirmed gastric adenocarcinoma,
             including Siewert III gastroesophageal junction adenocarcinoma, confirmed by the NCI
             Laboratory of Pathology, and have provided a block or unstained slides of primary or

             metastatic tumor tissue or newly obtained fresh biopsy of a tumor lesion in case
             archival tissue sample is not available.

          2. Patients may be treatment na(SqrRoot) ve or have received systemic chemotherapy prior
             to enrollment:

               -  Trastuzumab allowed as prior treatment for HER2/neu over-expressing cancers as
                  clinically indicated.

               -  Last dose of chemotherapy at least 4 weeks prior to enrollment with recovery to
                  Grade 1 from chemotherapy-related toxicities.

          3. Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of
             peritoneal carcinomatosis found at staging laparoscopy.

          4. Age >=18 years. Children under the age of 18 will not participate in this study as
             gastric cancer is rare in this population.

          5. ECOG performance status <=1

          6. Patients must have normal organ and marrow function as defined below:

             hemoglobin >=8.0 g/dL

             absolute neutrophil count >=1,000/mcL

             platelets >=100,000/mcL

             total bilirubin <=1.5 X institutional upper limit of normal

             AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal

             creatinine <1.5 mg/dl

             OR

             creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels above
             institutional normal.

          7. Physiologically able to undergo laparoscopy and systemic chemotherapy.

          8. Ability of subject to understand and the willingness to sign a written informed
             consent document.

          9. Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage
             is permitted.

         10. Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study treatment. Should a woman become pregnant or suspect she is
             pregnant while she or her partner is participating in this study, she should inform
             her treating physician immediately.

         11. Patients must be co-enrolled in protocol 13C0176 (NCT01915225) and 17C0044
             (NCT03027427) for sample collection.

         12. HIV-positive patients may be considered for this study only after consultation with a
             NIAID physician.

        EXCLUSION CRITERIA:

          1. Patients who are receiving any other investigational agents.

          2. Previous cytoreductive surgery or intraperitoneal chemotherapy.

          3. Disseminated extra-peritoneal or solid organ metastases:

               -  Excludes greater omentum and ovarian metastases.

               -  Radiographic signs or clinical symptoms consistent with malignant bowel
                  obstruction.

          4. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Paclitaxel or Capecitabine or other agents used in study.

          5. Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of
             disease.

          6. Existing peripheral neuropathy, Grade 3 or greater.

          7. Past medical history of dihydropyrimidine dehydrogenase deficiency.

          8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          9. Patients on therapeutic anticoagulation; Note: Prophylactic anticoagulation (i.e.
             intralumenal heparin) for venous or arterial access devices is allowed.

         10. Pregnant women are excluded because paclitaxel and capecitabine can cause fetal harm
             when administered to pregnant women. Because there is an unknown but potential risk
             for adverse events in nursing infants secondary to treatment of the mother with
             paclitaxel and capecitabine, breastfeeding should be discontinued if the mother is
             treated with paclitaxel and capecitabine.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment