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New treatment option for Clinical Stage IV Gastric Cancer AJCC v8
Official title PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
ClinicalTrials.gov ID: NCT04329494
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clinical stage iv gastric cancer ajcc v8.
Also referred to as Abiplatin, Blastolem.
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 studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 years
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
- Documented informed consent of the participant and/or legally authorized representative
- Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC
- Prior IP chemotherapy is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
- Absolute neutrophil count (ANC) \>= 1500/mm\^3
You likely can't join if
- Gastric and colorectal/appendiceal:
- Extra-peritoneal metastatic disease
- Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or...
- Arm 2 (colorectal/appendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency
- Arm 2 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral...
- Arm 2 (colorectal/appendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative
- Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC
- Prior IP chemotherapy is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
- Absolute neutrophil count (ANC) \>= 1500/mm\^3
- Platelets \>= 100,000/mm\^3
- Hemoglobin \>= 9 g/dl
- Serum total bilirubin =\< 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =\< 2.5 x ULN, unless liver metastases (Arm 1) are...
- Alkaline phosphatase =\< 2 x ULN
- Serum creatinine (sCr) =\ = 40 ml/min as calculated by the Cockcroft-Gault formula
- No contraindications for a laparoscopy
- The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy
- Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a known 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...
- Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of...
- Amenorrhea \>= 12 consecutive months without another cause or
- For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods...
- INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:
- PIPAC access is feasible
- There is room for aerosol therapy
- There is no evidence of impending bowel obstruction
- =\< 5 L of ascites
- Not a candidate for cytoreduction and HIPEC
What rules you out
- Gastric and colorectal/appendiceal:
- Extra-peritoneal metastatic disease
- Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
- Arm 2 (colorectal/appendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency
- Arm 2 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
- Arm 2 (colorectal/appendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds
- Arm 2 (colorectal/appendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia, hearing loss, or...
- Arm 2 (colorectal/appendiceal): Life expectancy of less than 6 months
- Arm 2 (colorectal/appendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents
- Arm 2 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used
- Arm 2 (colorectal/appendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents
- Arm 2 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis
- Arm 2 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection
- Arm 2 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial...
- Arm 2 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
- Arm 2 (colorectal/appendiceal): Involvement in the planning and conduct of the study
- Arm 2 (colorectal/appendiceal): Pregnancy
- Arm 2 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Arm 2 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD)...
- Arm 2 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
- Arm 2 (colorectal/appendiceal): Exclusive total parenteral nutrition
- Arm 2 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
- Arm 3 (colorectal/appendiceal): Progression on first- AND second-line systemic therapy
- Arm 3 (colorectal/appendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy
- Arm 3 (colorectal/appendiceal): Intolerance to prior 5-FU at 2400mg/m\^2 IV every 2 weeks or to irinotecan at 180mg/m\^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of \>...
- Arm 3 (colorectal/appendiceal): Known DPD deficiency
- Arm 3 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
- Arm 3 (colorectal/appendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia, hearing loss, or...
- Arm 3 (colorectal/appendiceal): Life expectancy of less than 6 months
- Arm 3 (colorectal/appendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents
- Arm 3 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used
- Arm 3 (colorectal/appendiceal): Patients may not be receiving any other investigational anti-cancer agents
- Arm 3 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis
- Arm 3 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection
- Arm 3 (colorectal/appendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial...
- Arm 3 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
- Arm 3 (colorectal/appendiceal): Involvement in the planning and conduct of the study
- Arm 3 (colorectal/appendiceal): Pregnancy
- Arm 3 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Arm 3 (colorectal/appendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD)...
- Arm 3 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
- Arm 3 (colorectal/appendiceal): Exclusive total parenteral nutrition
- Arm 3 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Jacksonville, Florida, United States
- Greenlawn, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 3 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 Duarte, California, United States; Jacksonville, Florida, United States; Greenlawn, New York, 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.