Sequential chemotherapy with intraperitoneal Paclitaxel for gastric cancer
Phase II Trial of Sequential Systemic Therapy Plus Intraperitoneal Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis (STOPGAP)
This study is testing a new way to treat advanced stomach cancer by using a combination of regular and special chemotherapy directly in the abdomen to see if it helps patients feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT04762953 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the safety and efficacy of a combination of systemic and intraperitoneal chemotherapy in patients with primary gastric or gastroesophageal junction adenocarcinoma that has spread to the peritoneum. Eligible patients will receive systemic therapy for 3-4 months, followed by diagnostic laparoscopy and placement of an intraperitoneal port if they show no distant organ metastasis. The intraperitoneal regimen includes Paclitaxel, Fluorouracil, and Leucovorin, administered over several cycles. Patients will be monitored for treatment response and may undergo further interventions based on their disease status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with confirmed gastric or gastroesophageal junction adenocarcinoma and positive peritoneal cytology who have not experienced distant metastasis.
Not a fit: Patients with distant organ metastasis or those with significant comorbidities affecting their performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced gastric cancer and peritoneal carcinomatosis.
How similar studies have performed: Other studies have shown promise with similar intraperitoneal chemotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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: 1. Leukocytes: ≥ 2,000/mcL 2. Absolute Neutrophil Count: ≥ 1,500/mcL 3. Platelets: ≥ 80,000/mcL 4. Total Bilirubin: within normal institutional limits 5. AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal 6. Creatinine: \< 1.5 X institutional upper limit of normal 7. Hemoglobin: \> 8.0 g/dL (may be transfused) 8. Serum albumin: ≥ 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: 1. Ongoing or active infection 2. Symptomatic congestive heart failure 3. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment 4. Unstable angina pectoris 5. 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
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Maheswari Senthil, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-7883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.