Clinical trial · Interventional
Feasibility Study of Intraperitoneal Paclitaxel
Feasibility Study of Intraperitoneal Paclitaxel With Oxaliplatin and Capecitabine in Patients With Advanced Gastric Cancer
NCT01739894CI-TRIAL-00022511unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IP Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IP Paclitaxel
- description
- Paclitaxel will be administered intraperitoneally at 40mg/m2 on Days 1 and 8 in a 21-day cycle in patients receiving intravenous oxaliplatin 100mg/m2 on Day 1 and capecitabine 1000mg/m2 twice daily on Days 1-14.
- interventionNames
- Drug: IP Paclitaxel
Primary outcomes (1)
- measure
- Overall survival (OS) rate
- timeFrame
- 1 year
- description
- The primary end point is 1-year survival because most patients may not have measurable disease, hence response rate and progression free survival are less easy to assess.
Secondary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDIshigami H, Kaisaki S, Yamaguchi H et al. Phase I study of weekly intraperitoneal paclitaxel combined with S-1 and oxaliplatin for gastric cancer with peritoneal metastasis. J Clin Oncol 30, 2012 (suppl 4; abstr 146)
- BACKGROUNDKim GM, Jeung HC, Rha SY, Kim HS, Jung I, Nam BH, Lee KH, Chung HC. A randomized phase II trial of S-1-oxaliplatin versus capecitabine-oxaliplatin in advanced gastric cancer. Eur J Cancer. 2012 Mar;48(4):518-26. doi: 10.1016/j.ejca.2011.12.017. Epub 2012 Jan 12. PMID 22243774
- BACKGROUNDIshigami H, Kitayama J, Kaisaki S, Hidemura A, Kato M, Otani K, Kamei T, Soma D, Miyato H, Yamashita H, Nagawa H. Phase II study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 for advanced gastric cancer with peritoneal metastasis. Ann Oncol. 2010 Jan;21(1):67-70. doi: 10.1093/annonc/mdp260. Epub 2009 Jul 15. PMID 19605503
- DERIVEDChia DKA, Ang JJ, Sundar R, Kim G, Shabbir A, So JBY, Yong WP. ASO Author Reflections: Combination Intra-Peritoneal and Systemic Chemotherapy for Gastric Cancer with Peritoneal Metastases. Ann Surg Oncol. 2022 Dec;29(13):8606-8607. doi: 10.1245/s10434-022-12102-1. Epub 2022 Oct 3. No abstract available. PMID 36192514