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Testing the Addition of Paclitaxel Administered into the Abdominal Cavity Combined with Chemotherapy for Patients with Gastric Cancer Spread to the Abdominal Cavity, STOPGAP II Trial
Trial Status: active
This phase II/III trial compares the effect of adding paclitaxel given into the abdominal cavity (intraperitoneal) to leucovorin, fluorouracil, and intravenous paclitaxel versus (vs) usual systemic therapy in treating patients with gastric or gastroesophageal cancer that has spread to the abdominal cavity. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Leucovorin calcium, a type of chemoprotective agent and a type of chemosensitizing agent, is a form of folic acid that is used to lessen the toxic effects of substances that block the action of folic acid. Fluorouracil, a type of antimetabolite, stops cells from making deoxyribonucleic acid and it may kill tumor cells. The usual approach to treatment is systemic therapy including chemotherapy and immunotherapy. Systemic therapy is any usual treatment, including chemotherapy and immunotherapy, using substances that travel through the bloodstream, reaching and affecting cells all over the body. Chemotherapy drugs 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. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding intraperitoneal paclitaxel to leucovorin, fluorouracil and intravenous paclitaxel may be better at preventing the tumor from growing or spreading compared to usual systemic therapy in patients with gastric or gastroesophageal cancer that has spread to the abdominal cavity.
Inclusion 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 synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H/dMMR) mismatch repair deficient disease are not eligible
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 laparoscopy procedure followed by further systemic and intraperitoneal therapy
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 Functional Classification. To be eligible for this trial, patients should be class II or better
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 registration)
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 efficacy assessment of the investigational regimen are eligible for this trial
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 not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
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 patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment
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 caregiver and/or family member available will also be considered eligible
STEP 1 RANDOMIZATION:
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
Additional locations may be listed on ClinicalTrials.gov for NCT07001748.
Locations matching your search criteria
United States
California
Irvine
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
I. In the phase II portion, to determine the progression free survival (PFS) from randomization.
II. In the phase III portion, to determine overall survival (OS) from randomization.
SECONDARY OBJECTIVE:
I. To compare the safety and tolerability of the intraperitoneal chemotherapy + systemic therapy regimen vs the systemic therapy alone regimen.
OUTLINE:
STEP 0: Patients undergo diagnostic laparoscopy within 4 weeks of study registration.
STEP 1: Patients are randomized to 1 of 2 arms at the time of Step 0 diagnostic laparoscopy.
ARM A: Patients receive standard of care systemic therapy per physician's choice. Patients with stable disease or a response after 12 weeks may continue to receive standard of care treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study and may undergo additional diagnostic laparoscopies as clinically indicated.
ARM B: Patients undergo placement of an intraperitoneal port. Patients receive leucovorin calcium intravenously (IV) over 15-30 minutes, fluorouracil IV push, paclitaxel IV over 1-2 hours and paclitaxel intraperitoneally (IP) on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease or a response after 12 weeks may continue to receive treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and CT and/or MRI throughout the study and may undergo additional diagnostic laparoscopies as clinically indicated.
After completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months for up to 5 years after Step 1 randomization.
