Perioperative Paclitaxel for Stomach Cancer

Phase 2

Recruiting

Led By Brian Badgwell, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial examines how paclitaxel and gastrectomy can improve outcomes in gastric cancer patients.

Who is the study for?

This trial is for adults with gastric adenocarcinoma and either positive peritoneal cytology or carcinomatosis. Participants must have completed preoperative chemotherapy, have adequate organ function, and not be pregnant or breastfeeding. They should also agree to use effective contraception. Excluded are those with severe heart conditions, life-threatening reactions to certain chemotherapies, infections that could interfere with the study, other distant metastases outside the peritoneum, or previous surgeries preventing safe treatment.

What is being tested?

The trial studies the effects of paclitaxel (a chemotherapy drug) combined with gastrectomy (surgical removal of all or part of the stomach) on patients with gastric cancer. It aims to understand how this combination can improve patient outcomes.

What are the potential side effects?

Paclitaxel may cause side effects like allergic reactions, blood disorders such as low white cell count increasing infection risk, nerve damage leading to numbness or pain in hands/feet (neuropathy), muscle and joint pain, nausea/vomiting controlled by medications like dexamethasone and famotidine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PaclitaxelExperimental Treatment4 Interventions

Participant will receive paclitaxel every 2 weeks for 6 weeks, and then participants may have a gastrectomy based on what the doctor thinks is in your best interest. You may then receive additional paclitaxel every 2 weeks for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Diphenhydramine

2002

Completed Phase 4

~1170