Phase II Basket Trial of Intraperitoneal Paclitaxel Plus Systemic Therapy in Gastrointestinal Malignancies With Peritoneal Carcinomatosis (STOPGAP - B)
This is a phase II open-label, basket clinical trial to assess the feasibility of systemic and Intraperitoneal chemotherapy in subjects with Gastrointestinal Malignancies with Peritoneal Carcinomatosis. These are subjects who have a proven primary carcinoma of the digestive tract..
• Cohort A: Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma with a clinical diagnosis of metachronous PC with a history of prior gastric cancer resection. Extraperitoneal metastases are allowed.
• Cohort B: Patients must have histologically or cytologically confirmed primary colorectal or appendiceal adenocarcinoma with PC . Extraperitoneal metastases are allowed. Patients with PC amenable to cytoreductive surgery (CRS) without the need for upfront systemic therapy as determined by a peritoneal malignancy surgeon within 4 weeks prior to enrollment are excluded.
• Cohort C: Patients must have adenocarcinomas of the digestive tract with PC not included in Cohorts A and B (including but not limited to carcinomas of the small bowel and hepatobiliary tract).
• Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy
• Age ≥ 18
• Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed if attributed to malignancy (rather than comorbidities)
• Life expectancy of greater than 3 months
• Adequate organ and marrow function as defined below: Leukocytes: ≥ 2,000/mcL; Absolute neutrophil count: ≥ 1,500/mcL (may receive gcsf); Platelets: ≥ 70,000/mcl (may receive TPO); Total bilirubin: within 2x of normal institutional limit; AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal; Creatinine: \< 2 X institutional upper limit of normal; Hemoglobin: Hemoglobin \> 8.0 g/dL (may be transfused); Serum albumin: ≥ 2.5 g/dL
• Ability to understand and the willingness to sign a written informed consent