Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases

NCT06675136 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 24445NCI-2024-08883P30CA033572
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clinical Stage IVB Gastric Cancer AJCC v8; Metastatic Gastric Adenocarcinoma; Metastatic Malignant Neoplasm in the Peritoneum

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  Will be evaluated and graded based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Toxicities will be summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome. Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated.

  Up to 6 weeks after the first pressurized intraperitoneal aerosolized chemotherapy (PIPAC) treatment

Secondary Outcomes (12)

• Incidence of treatment-related adverse events (AEs)

  Up to 4 weeks after last dose of nab-paclitaxel

• Incidence of post-operative surgical complications

  At 4 weeks post-PIPAC procedure

• Objective response rate (ORR)

  Up to 2 years

• Peritoneal Carcinomatosis Index (PCI)

  At time of laparoscopy

• Peritoneal Regression Grading Score (PRGS)

  At baseline and post-PIPAC, assessed up to 2 years

Study Arms (1)

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Medical Device Usage and Evaluation; Drug: Nab-paclitaxel; Drug: Paclitaxel; Other: Questionnaire Administration; Biological: Ramucirumab

Interventions

Biopsy PROCEDURE

Undergo tumor biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Medical Device Usage and Evaluation OTHER

Given PIPAC

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Nab-paclitaxel DRUG

Given IP

Also known as: ABI 007, ABI-007, ABI007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Naveruclif, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Paclitaxel Nanoparticle Albumin-bound, Paclitaxel Protein-Bound, Protein-bound Paclitaxel

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Questionnaire Administration OTHER

Ancillary studies

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Ramucirumab BIOLOGICAL

Given IV

Also known as: Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC 1121B, IMC-1121B, IMC1121B, LY 3009806, LY-3009806, LY3009806, Monoclonal Antibody HGS-ETR2

Treatment (nab-paclitaxel PIPAC, paclitaxel, ramucirumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin \[FOLFOX\] with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy)
• Prior immunotherapy allowed
• Up to 4 cycles of second-line therapy allowed if no progression is documented
• Documented informed consent of the participant and/or legally authorized representative
• Assent, when appropriate, will be obtained per institutional guidelines
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Age: ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed gastric adenocarcinoma
• Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by RECIST 1.1)
• Fully recovered from acute toxic effects (except alopecia, hearing loss, or non-clinically significant laboratory abnormalities) ≤ grade 1 of prior anti-cancer therapy
• The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine must be collected and must demonstrate \< 1000mg protein in 24 hours
• Complete medical history and physical exam (within 28 days prior to day 1 of protocol therapy)
• Absolute neutrophil count (ANC) ≥ 1,500/mcL (within 28 days prior to day 1 of protocol therapy)

You may not qualify if:

• Intolerance to taxanes
• Bowel obstruction requiring exclusive total parenteral nutrition
• Any history of, or current, brain or subdural metastases
• Life expectancy \< 3 months
• Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment
• Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved
• Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (taxanes, etc.)
• Clinically significant uncontrolled illness such as uncontrolled hypertension (HTN)
• History of arterial thromboembolic events such as myocardial infarction (MI), cerebrovascular accident (CVA)
• History of gastrointestinal (GI) perforation
• FEMALES ONLY: 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
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Interventions

Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; Paclitaxel; Ramucirumab

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Yanghee Woo

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: October 29, 2025
• Primary Completion (Estimated): January 14, 2029
• Study Completion (Estimated): January 14, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)