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New treatment option for Clinical Stage IVB Gastric Cancer AJCC v8
Official title Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases
ClinicalTrials.gov ID: NCT06675136
What this study is testing
What is Nab-paclitaxel?
Nab-paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clinical stage ivb gastric cancer ajcc v8.
Also referred to as ABI 007, ABI-007.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin [FOLFOX] with or without immunotherapy, or other...
- 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
You likely can't join 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
What rules you out
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.