Feasibility Study of Intraperitoneal Paclitaxel

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm phase 2 trial evaluating the efficacy and tolerability of intraperitoneal paclitaxel with oxaliplatin and capecitabine in advanced gastric cancer patients with peritoneal metastasis and/or cancer cells on peritoneal cytology. Twenty patients will be recruited into the study for an estimated period of two years. Paclitaxel will be administered intraperitoneally at 40mg/m2 on Day 1 and 8 in patients receiving standard intravenous oxaliplatin 130mg/m2 on Day 1 and capecitabine 1000mg/m2 on day 1-14. The study hypothesizes that the addition of intraperitoneal paclitaxel with chemotherapy will improve treatment efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically proven unresectable or recurrent adenocarcinoma of stomach and gastroesophageal junction

• Patients without prior systemic treatment. Patients who completed postoperative adjuvant chemotherapy (and radiotherapy) more than 180 days before may be enrolled

• Peritoneal metastasis and/or cancer cells on peritoneal cytology

• Age >21 years

• Eastern Cooperative Oncology Group performance status 0-2

• Adequate bone marrow function (neutrophil count >1500/mm3, hemoglobin >8.0 g/dl and platelet count >100 000/mm3)

• Adequate liver function (bilirubin, AST (aspartate aminotransferase)/ALT (alanine aminotransferase) within upper limit of normal)

• Adequate renal function (serum creatinine within the upper limit of normal)

• Expected survival >3 months

• Able to take orally

• Able to understand and the willingness to sign a written informed consent document

• The effects of proposed regimen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antitumor agents as well as other therapeutic agents used in this trial are known to be teratogenic, 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

• Metastasis to distant organ sites (such as the liver, lungs or bone)

• When trastuzumab is considered for palliative chemotherapy

• Known allergy to taxane, fluoropyrimidine or oxaliplatin

• Previous malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix

• Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients)

• Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant or lactating female