Genetic analysis-guided dosing of chemotherapy for advanced stomach cancer
PERIOP-FOLFIRINOX: A Pilot Trial of Perioperative Genotype-guided Irinotecan Dosing of gFOLFIRINOX for Locally Advanced Gastroesophageal Adenocarcinoma
This study is testing if using genetic information to tailor chemotherapy doses can help people with advanced stomach cancer have better treatment results and fewer side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT02366819 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of genetic analysis to guide the dosing of irinotecan hydrochloride in combination with other chemotherapy agents (mFOLFIRINOX) for patients with locally advanced gastroesophageal or stomach cancer. The study aims to determine the effectiveness of this personalized approach by measuring tumor resection rates and pathologic complete response after treatment. Patients will receive a specific regimen of chemotherapy followed by surgery, with the potential for improved outcomes based on their genetic profiles. The trial also evaluates secondary outcomes such as chemotherapy-related toxicity and overall survival.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed locally advanced gastric or esophagogastric adenocarcinoma who are eligible for surgery with curative intent.
Not a fit: Patients with metastatic disease or those with distal gastric adenocarcinomas may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized chemotherapy treatments for patients with advanced stomach cancer.
How similar studies have performed: Other studies have shown promise with genetic-guided dosing approaches in cancer treatment, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed locally advanced gastric (primary endpoint includes proximal and mid-body stomach) or esophagogastric adenocarcinoma; distal gastric (antral) adenocarcinomas are eligible for enrolment but will not be included in the primary analysis * Locally advanced disease as determined by endoscopic ultrasound (EUS) stage \> primary tumor (T) 3 and/or any T, lymph nodes (N)+ disease without metastatic disease (Mx) * All patients must have diagnostic laparoscopy with diagnostic washings for cytology; both cytology positive and negative patients are eligible for enrolment, but only cytology negative patients will be included in the primary analyses; gross peritoneal disease is not eligible * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Eligible for surgery with curative intent * Absolute neutrophil count (ANC) \>= 1250/ul * Hemoglobin \>= 9 g/dL * Platelets \>= 100,000/ul * Total bilirubin \< 1.5 x upper limit of normal * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 2.5 x upper limit of normal for patients without liver metastases OR SGOT and SGPT \< 5 x upper limit of normal for patients with liver metastases * Creatinine =\< 1.5 x upper limit of normal * Measurable or non-measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 will be allowed * 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 and for the duration of study participation, up until 30 days after final study treatment; should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately * Patients taking substrates, inhibitors, or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan * Signed informed consent Exclusion Criteria: * Previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30% * Inflammatory bowel disease that is uncontrolled or on active treatment (Crohn's disease, ulcerative colitis) * Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version \[v\] 4.0) * Neuropathy, grade 2 or greater by NCI-CTCAE, v 4.0 * Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment * Active uncontrolled bleeding * Pregnancy or breastfeeding * Major surgery within 4 weeks * Patients with any polymorphism in UGT1A1 other than \*1 or \*28 (e.g, \*6) will be allowed and treated as in the \*28/\*28 dosing group
Where this trial is running
Chicago, Illinois and 2 other locations
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (Recruiting)
- Kellogg Cancer Center - Evanston Hospital — Evanston, Illinois, United States (Recruiting)
- NorthShore University HealthSystem — Evanston, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Catenacci — University of Chicago Comprehensive Cancer Center
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.