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

Launched by CITY OF HOPE MEDICAL CENTER · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with advanced stomach cancer that has spread to the lining of the abdominal cavity, known as peritoneal metastases. The study is testing a combination of three medications: nab-paclitaxel, which is a special form of chemotherapy delivered as a fine mist directly into the abdominal cavity, paclitaxel, and ramucirumab. This combination aims to determine the safest dosage and how well it works in treating this specific type of cancer.

To be eligible for this trial, participants must be at least 18 years old and have already tried other treatments for their stomach cancer without success. They should have visible cancer in the abdominal lining, a good performance status (meaning they are generally well enough to participate), and must meet certain health criteria. If you or a loved one are considering joining this trial, you can expect to receive close monitoring and support throughout the treatment process, as well as the opportunity to contribute to important research that could help others with the same condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• • Platelets ≥ 100,000/mcL (within 28 days prior to day 1 of protocol therapy)
• • Hemoglobin ≥ 8 g/dL (within 28 days prior to day 1 of protocol therapy)
• • Serum albumin ≥ 2.8 g/dL (within 28 days prior to day 1 of protocol therapy)
• • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin \< 1.5 mg/dL) (within 28 days prior to day 1 of protocol therapy)
• • Aspartate aminotransferase (AST) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)
• • Alanine aminotransferase (ALT) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)
• • International normalized ratio (INR) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)
• • Prothrombin time (PT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)
• • Partial thromboplastin time (PTT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)
• • Calculated creatinine clearance of ≥ 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 28 days prior to day 1 of protocol therapy)
• • Seronegative for HIV antigen (Ag)/antibody (Ab) combo (within 28 days prior to day 1 of protocol therapy)
• • If seropositive, patient may be eligible if they are stable on antiretroviral therapy, have a CD4 T cell count ≥ 200/µL, and have an undetectable viral load
• • Documented virology status of hepatitis, confirmed by hepatitis B virus (HBV) and hepatitis C virus (HCV) tests (within 28 days prior to day 1 of protocol therapy)
• • For patients with active HBV, HBV deoxyribonucleic acid (DNA) \< 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to day 1 of cycle 1, and willingness to continue anti-HBV treatment during the study (per standard of care)
• • If seropositive for HCV, nucleic acid quantification must be performed. Viral load must be undetectable
• • WOMEN OF CHILDBEARING POTENTIAL (WOCBP): Negative urine or serum pregnancy test (within 28 days prior to day 1 of protocol therapy)
• • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• • Agreement by females and males of childbearing potential to use an effective method of birth control (e.g., licensed hormonal/barrier methods or surgery intended to prevent pregnancy \[or with a side effect of pregnancy prevention\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy.
• • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
• Exclusion Criteria:
• • 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)