Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis

NCT04762953 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20206178UCI 20-87
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II clinical trial assessing the safety and efficacy of sequential systemic and intraperitoneal (IP) chemotherapy in patients with primary gastric/gastroesophageal junction cancer with cytology positive peritoneal lavage and/or peritoneal carcinomatosis.

Conditions

Gastroesophageal Junction Adenocarcinoma; Gastric Cancer; Peritoneal Carcinomatosis

Keywords

Gastric Cancer; Peritoneal Carcinomatosis; Gastroesophageal Junction (GEJ) Adenocarinoma; Paclitaxel; 5-FU; Fluorouracil; Leucovorin

Outcome Measures

Primary Outcomes (2)

• Participants with Progression Free Survival at 1-Year

  Progression-free survival is defined as the duration of time from start of systemic treatment to time of progression, death, or clinical deterioration attributed to disease progression as judged by the investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm and/or appearance of new lesions.

  1 year

• Incidence of Treatment-Emergent Adverse Events [Safety]

  To evaluate the safety of IP paclitaxel and IV paclitaxel, 5-FU, and leucovorin in patients with primary gastric/GEJ adenocarinoma with peritoneal carcinomatosis determined by the incidence of treatment-emergent adverse events. Adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

  From date of study treatment initiation to first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, assessed up to 12 months after the last patient is enrolled.

Secondary Outcomes (2)

• Overall Survival of Participants

  From initiation of systemic treatment to up to 12 months after last patient is enrolled or until death from any cause.

• Patient Reported Quality of Life Outcomes

  From initiation of study treatment until patient is off study, assessed up to 12 months after the last patient has started treatment.

Other Outcomes (2)

• Expression of Plasma and Ascites Exosomal Gene Signature (EXOSIG)

  From date of registration to up to 12 months after last patient is enrolled.

• Correlation of Plasma and Ascite Exosomal Gene Signature (EXOSIG) to Treatment Response

  From date of registration to up to 12 months after last patient is enrolled.

Study Arms (1)

SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis

EXPERIMENTAL

Patients will receive sequential intraperitoneal paclitaxel along with intravenous paclitaxel, 5-FU, and leucovorin on Days 1 and 8 of every 21 day cycle for 3 months.

Drug: Paclitaxel; Drug: Leucovorin; Drug: Fluorouracil

Interventions

Leucovorin DRUG

IV Leucovorin

SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis

Fluorouracil DRUG

IV 5-FU

Also known as: 5-FU

SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis

Paclitaxel DRUG

Intraperitoneal Paclitaxel

SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed is attributed to malignancy (rather than comorbidities)
• Life expectancy of greater than 6 months
• Adequate organ and marrow function as defined below:
• Leukocytes: ≥ 2,000/mcL
• Absolute Neutrophil Count: ≥ 1,500/mcL
• Platelets: ≥ 80,000/mcL
• Total Bilirubin: within normal institutional limits
• AST(SGOT)/ALT(SPGT): ≤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: ≥ g/dL
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location

Related Publications (1)

• Senthil M, Dayyani F. Phase II clinical trial of sequential treatment with systemic chemotherapy and intraperitoneal paclitaxel for gastric and gastroesophageal junction peritoneal carcinomatosis - STOPGAP trial. BMC Cancer. 2023 Mar 4;23(1):209. doi: 10.1186/s12885-023-10680-1.

  PMID: 36870941 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Paclitaxel; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Maheswari Senthil, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This clinical trial is a non-randomized, open label, single arm clinical trial.

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: February 18, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)