Trial Summary
What is the purpose of this trial?This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.
Eligibility Criteria
This trial is for stomach cancer patients with peritoneal metastases, who are ready to try a combination of treatments. Participants should be suitable for second-line chemotherapy and have not had prior PIPAC or allergic reactions to the drugs used in this study.Inclusion Criteria
I am 18 years old or older.
My urine protein levels are low or normal.
I've had a full medical check-up in the last 28 days.
+30 more
Exclusion Criteria
I cannot tolerate taxane medications.
I am not pregnant or breastfeeding.
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
+11 more
Participant Groups
The trial tests nab-paclitaxel PIPAC's safety and optimal dose when combined with paclitaxel and ramucirumab. It evaluates how well these treatments work against stomach cancer that has spread to the abdominal lining.
1Treatment groups
Experimental Treatment
Group I: Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)Experimental Treatment9 Interventions
Patients receive nab-paclitaxel PIPAC IP over 40 minutes on day 1 and SOC paclitaxel IV over 60 minutes on days 15, 22, 29, 43, and 50 and ramucirumab IV over 30-60 minutes on days 15, 29 and 43 of each cycle. Cycles repeat every 8 weeks (56 days) for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may then continue SOC paclitaxel IV on days 1, 8, and 15 and ramucirumab IV on days 1 and 15 of each cycle per physician as deemed appropriate. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, tumor biopsy, and CT or MRI throughout the study.
Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Abraxane for:
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
🇪🇺 Approved in European Union as Abraxane for:
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
🇨🇦 Approved in Canada as Abraxane for:
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
Loading ...
Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator