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New treatment option for Gastric Adenocarcinoma
Official title Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity
ClinicalTrials.gov ID: NCT07001748
What this study is testing
What is Intraperitoneal Paclitaxel?
Intraperitoneal Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric adenocarcinoma.
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 study is being done to answer the following questions: Can we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer?
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
- Which group you join is decided by chance.
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
- STEP 0 REGISTRATION:
- Patient must be at least 18 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient...
- Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment
See the full eligibility criteria
- STEP 0 REGISTRATION:
- Patient must be at least 18 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with...
- Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment
- Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic...
- Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy
- Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration
- Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy
- Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy
- Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement
- Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous
- Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin
- Leukocytes ≥ 2,000/uL (≤ 30 days prior to Step 0 registration)
- Absolute neutrophil count (ANC) ≥ 1,500/uL (≤ 30 days prior to Step 0 registration)
- Platelets ≥ 75,000/uL (≤ 30 days prior to Step 0 registration)
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be \< 2.0 mg/dL (≤ 30 days prior to Step 0 registration)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0...
- Creatinine clearance ≥ 30 mL/min (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration)
- Hemoglobin ≥ 8 g/dL (≤ 30 days prior to Step 0 registration)
- Serum albumin ≥ 2.5 g/dL (≤ 30 days prior to Step 0 registration)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
- All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy
- A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has...
- Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A...
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or...
- Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained
- The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available
- Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Waterbury, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- DeKalb, Illinois, United States
- Geneva, Illinois, United States
- Oak Brook, Illinois, United States
- Shiloh, Illinois, United States
- Warrenville, Illinois, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Kalamazoo, Michigan, United States
+ 28 more site(s).
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States and 42 more location(s). 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.