Phase II Trial of Sequential Systemic Therapy Plus Intraperitoneal Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis
Details
The purpose of this research study is to see if sequential intravenous chemotherapy followed by intraperitoneal chemotherapy with paclitaxel combination is safe and will improve cancer control in patients who have gastric cancer that is spread in the abdominal lining ( peritoneum) called peritoneal carcinomatosis (PC). Currently, patients with gastric cancer who have cancer spread to the abdominal lining are only treated with intravenous chemotherapy, which is chemotherapy administered through the vein into the body. We are proposing to add intraperitoneal chemotherapy (chemotherapy infused into the abdominal cavity through a small access device implanted into the abdominal fat tissue) to the usually used intravenous chemotherapy, to study if this combination improves survival in patients.
Eligibility
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Eligibility Criteria:
Inclusion Criteria:
Patients must have confirmed primary gastric or gastroesophageal cancer and have received a minimum of 3 months of first line treatment without visceral (liver, lung, brain) metastases.
Patients must have peritoneal cytology positive disease or peritoneal carcinomatosis.
Exclusion Criteria:
Patients must not have had systemic treatment for unresectable or metastatic disease for more than 3 months prior to enrollment.
Patients must not have any evidence of distant, solid organ metastes (visceral (liver, lung, brain), bone, extra-abdominal).
Patients must not have any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy.