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Intravenous Leucovorin, Fluorouracil, Paclitaxel and Intraperitoneal Paclitaxel for the Treatment of Stomach Cancer with Peritoneal Carcinomatosis, STOPGAP Study

Trial Status: Active

This phase II trial studies the effect of intravenous leucovorin, fluorouracil, paclitaxel and intraperitoneal paclitaxel in treating patients with stomach cancer that has spread in the abdominal lining (peritoneum) called as peritoneal carcinomatosis. Currently, patients with gastric cancer who have cancer spread to the abdominal lining are only treated with intravenous chemotherapy, which is chemotherapy administered through the vein into the body. Chemotherapy drugs, such as leucovorin, fluorouracil, and paclitaxel 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. Giving paclitaxel via infusion into the abdominal cavity through a small access device implanted into the abdominal fat tissue (intraperitoneal) together with intravenous chemotherapy may shrink tumor growth and improve survival in patients with stomach cancer and peritoneal carcinomatosis.

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma and have received a minimum of three months of first line systemic treatment without visceral metastatic progression
  • Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy
  • Age >= 18 - 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2. ECOG 2 allowed is attributed to malignancy (rather than comorbidities)
  • Life expectancy of greater than 6 months
  • Leukocytes >= 2,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 80,000/mcl
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional upper limit of normal
  • Creatinine < 1.5 x institutional upper limit of normal
  • Hemoglobin > 8.0 g/dL (may be transfused)
  • Serum albumin >= 2.5 g/dL
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

  • Systemic treatment for unresectable or metastatic disease for more than three months prior to enrollment
  • Any evidence of distant, solid organ metastases (visceral (liver, lung, brain), bone, extra-abdominal)
  • Any evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy
  • Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy
  • Uncontrolled intercurrent illness including, but not limited to, the following conditions: * Ongoing or active infection * Symptomatic congestive heart failure * Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment * Unstable angina pectoris * Cardiac arrhythmia
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy
  • Inability to comply with study and follow-up procedures as judged by the investigator
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Has an active infection requiring systemic therapy
  • Prior surgery that would preclude safe diagnostic laparoscopy and port placement
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Maheswari Senthil
Phone: 714-456-6015

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of sequential systemic chemotherapy followed by intraperitoneal paclitaxel in gastric/gastroesophageal junction adenocarcinoma (GEJ) (Siewert 3) with peritoneal carcinomatosis.

II. To assess 1-year progression free survival.

SECONDARY OBJECTIVES:

I. To assess the overall survival.

II. To assess quality of life outcomes.

EXPLORATORY OBJECTIVE:

I. To assess the expression of plasma and ascites exosomal gene signature (EXO SIG) in patients with gastric cancer peritoneal carcinomatosis.

OUTLINE:

Patients receive leucovorin intravenously (IV), fluorouracil IV, and paclitaxel IV and intraperitoneally (IP) on days 1 and 8. Cycles repeat every 21 days for 3 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
UC Irvine Health / Chao Family Comprehensive Cancer Center

Principal Investigator
Maheswari Senthil

  • Primary ID UCI 20-87
  • Secondary IDs NCI-2021-02025
  • Clinicaltrials.gov ID NCT04762953