Phase II Basket Trial of Intraperitoneal Paclitaxel plus Systemic Therapy in Gastrointestinal Malignancies with Peritoneal Carcinomatosis (STOPGAP - B)
Study Description
The purpose of this research study is to see if intraperitoneal chemotherapy with paclitaxel combined with systemic therapy is safe and will improve cancer control in patients like you who have cancer that is spread in the abdominal lining (peritoneum) called peritoneal carcinomatosis (PC). Currently, patients with intestinal tract 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 called a catheter or port implanted into the abdominal fat tissue) to the usually used intravenous chemotherapy, to study if this combination is safe and tolerable in patients like you. The rationale for this approach is explained below.
Past studies have shown that treatment with intravenous chemotherapy can slow the growth or spreading of cancer and increase survival rates in patients with gastrointestinal cancer who are not candidates for curative treatment (i.e. the disease cannot be surgically removed). However, this treatment is only able to control disease for about six months. After six months, most tumors will not respond to the treatment and grow again. When this happens, the chemotherapy needs to be changed but the goal remains palliative.
Intravenous chemotherapy alone may not be sufficient to treat peritoneal metastasis as evidence suggests that plasma peritoneal barrier reduces penetrance of chemotherapy in the peritoneal cavity. Hence tumor nodules in the peritoneal cavity may not receive adequate concentrations of chemotherapy. This could be overcome by placing the chemotherapy agents directly into the abdominal cavity.
Eligibility
You can participate in this study if you satisfy the following criteria:
• At least 18 years of age
• You have cancer of the intestinal tract that has previously been treated with surgery
• You have evidence of peritoneal carcinomatosis
• You have been treated with IV chemotherapy for more than six months in patients with gastric cancer.
• Life expectancy of greater than 3 months
You cannot participate in this study if you:
• Are pregnant or nursing, or planning to become pregnant or nurse
• Have an active infection requiring treatment, congestive heart failure, stroke within 3 months before starting treatment, unstable angina pectoris (unpredictable or resting chest pain), history of active tuberculosis, and/or cardiac arrhythmia (irregular heartbeat).
• Have evidence of small or large bowel obstruction
• Have a history of another type of cancer within the last 3 years, except for non-melanoma skin cancer, early-stage prostate cancer, or cervical carcinoma that has been treated and cured, and was not treated with systemic therapy, such as chemotherapy or other systemic drugs.
• Previous Intraperitoneal (IP) treatment.
