Actively Recruiting
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Led by M.D. Anderson Cancer Center · Updated on 2026-05-22
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of paclitaxel combined with gastrectomy (surgery to remove all or part of the stomach) on patients diagnosed with stage IV gastric or gastroesophageal cancer who have positive cytology or carcinomatosis. The main goal is to assess overall survival from diagnosis and to evaluate the safety of gastrectomy after perioperative intraperitoneal paclitaxel treatment. This is a Phase II clinical trial sponsored by M.D. Anderson Cancer Center. Participants receive paclitaxel by intraperitoneal injection every two weeks for six weeks. Depending on the doctor's recommendation, participants may then undergo gastrectomy surgery. After surgery, additional paclitaxel treatment is given every two weeks for another six weeks. Other supportive medications such as dexamethasone, diphenhydramine, and famotidine are also administered intravenously as part of the treatment regimen. During the study, participants will be monitored for adverse events using standard criteria throughout the average one-year follow-up period. Assessments will include evaluations of overall survival and treatment safety. The study involves regular visits for treatment administration, safety monitoring, and follow-up evaluations. Participation duration varies but involves perioperative treatment and monitoring over approximately one year.
CONDITIONS
Brief Title
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with no upper age limit
- ECOG performance status of 2 or less (Karnofsky 60% or higher)
- Cytologic or histologic confirmation of adenocarcinoma of the stomach or gastroesophageal junction
- Adequate kidney and bone marrow function: leukocytes ≥ 3,000/uL, absolute neutrophil count ≥ 1,500/uL, platelets ≥ 60,000/μL, serum creatinine ≤ 1.6 mg/dL
- Distant metastatic disease involving the peritoneum with positive cytology or carcinomatosis confirmed by laparoscopy or laparotomy
- Completion of preoperative systemic cytotoxic chemotherapy; targeted or immunotherapy may continue
- Open to English and non-English speaking patients
You will not qualify if you...
- Metastatic disease beyond the peritoneum such as to liver, brain, or lungs
- Active infections like pneumonia or wound infections that prevent treatment
- Positive pregnancy test or unwillingness to use adequate contraception or abstain from breastfeeding
- Unstable angina or congestive heart failure Grade II or higher
- Cognitive impairment or inability to comply with study procedures
- Known life-threatening hypersensitivity to systemic chemotherapy used in this protocol
- Previous surgery preventing safe tumor removal or intraperitoneal port placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 12 weeks
Participants receive paclitaxel every 2 weeks for 6 weeks before possibly undergoing gastrectomy, followed by additional paclitaxel every 2 weeks for 6 weeks.
6 visits every 2 weeks before surgery and 6 visits every 2 weeks after surgery
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Iqra Rehman, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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