Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Feb 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with gastric cancer or cancer at the gastroesophageal junction that has spread to the lining of the abdomen (peritoneal carcinomatosis). The trial is testing a combination of two types of chemotherapy: systemic chemotherapy, which is given through the bloodstream, followed by intraperitoneal chemotherapy, which is delivered directly into the abdominal cavity. The goal is to see if this sequence can be both safe and effective for patients who have already received some initial treatment but still have signs of cancer.

To participate, patients must be adults aged 18 to 75 with confirmed gastric or gastroesophageal adenocarcinoma. They should have had at least three months of initial treatment without significant progression of their disease and must have cancer detected in the abdominal lining. Participants will be closely monitored throughout the trial to ensure their safety and to track how well the treatment works. It’s important for potential participants to discuss any health concerns with their doctor, as certain conditions may prevent them from joining the trial.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma and have received a minimum of three months of first line systemic treatment without visceral metastatic progression
• • Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy
• • Age ≥ 18 -75 years
• • Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed is attributed to malignancy (rather than comorbidities)
• • Life expectancy of greater than 6 months
• * Adequate organ and marrow function as defined below:
• • 1. Leukocytes: ≥ 2,000/mcL
• • 2. Absolute Neutrophil Count: ≥ 1,500/mcL
• • 3. Platelets: ≥ 80,000/mcL
• • 4. Total Bilirubin: within normal institutional limits
• • 5. AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal
• • 6. Creatinine: \< 1.5 X institutional upper limit of normal
• • 7. Hemoglobin: \> 8.0 g/dL (may be transfused)
• • 8. Serum albumin: ≥ g/dL
• • Ability to understand and the willingness to sign a written informed consent
• Exclusion Criteria:
• • Systemic treatment for unresectable or metastatic disease for more than three months prior to enrollment
• • Any evidence of distant, solid organ metastases (visceral (liver, lung, brain), bone, extra-abdominal)
• • Any evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy
• • Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy
• * Uncontrolled intercurrent illness including, but not limited to, the following conditions:
• • 1. Ongoing or active infection
• • 2. Symptomatic congestive heart failure
• • 3. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment
• • 4. Unstable angina pectoris
• • 5. Cardiac arrhythmia
• • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.
• • Inability to comply with study and follow-up procedures as judged by the Investigator
• • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.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, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• • Has an active infection requiring systemic therapy.
• • Prior surgery that would preclude safe diagnostic laparoscopy and port placement
• • Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
• • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator