A Phase I Study of Intraperitoneal Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Who is this study for? Patients with gastric adenocarcinoma and carcinomatosis or positive cytology
What treatments are being studied? Paclitaxel
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This phase I trial studies the side effects and best dose of paclitaxel for the treatment of gastric or gastroesophageal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2

• Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction

• Leukocytes \>= 3,000/uL

• Absolute neutrophil count \>= 1,500/uL

• Platelets \>= 60,000/Ul

• Serum creatinine =\< 1.5 mg/dL

• Distant metastatic disease of peritoneum:

‣ Positive peritoneal cytology

⁃ Carcinomatosis on diagnostic laparoscopy or laparotomy

⁃ Completion of preoperative systemic chemotherapy

Locations
United States
Texas
M D Anderson Cancer Center
Houston
Time Frame
Start Date: 2019-12-06
Completion Date: 2028-10-30
Participants
Target number of participants: 27
Treatments
Experimental: Treatment (paclitaxel)
Patients receive paclitaxel IP over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov