Feasibility Study of Intraperitoneal Paclitaxel

NCT01739894 | Unknown Phase 2 DMC

• 1 other identifier: GA01/12/12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Advanced gastric cancer; unresectable gastric cancer; recurrent gastric cancer; with peritoneal metastasis; cancer cells on peritoneal cytology

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS) rate

  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.

  1 year

Secondary Outcomes (1)

• Number of participants with adverse events

  3-weekly

Study Arms (1)

IP Paclitaxel

EXPERIMENTAL

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.

Drug: IP Paclitaxel

Interventions

IP Paclitaxel DRUG

Each treatment cycle will consist of 21 days, with 14 days on treatment and 7 days off-treatment. Oxaliplatin will be administered intravenously (on Day 1 of each cycle). Paclitaxel will be administered intra-abdominally on Day 1 and Day 8 of each cycle. In particular, a needle will be inserted into the intraperitoneal injection port for normal saline to be injected intra-abdominally over one hour, followed by paclitaxel chemotherapy over a further one hour. Capecitabine will be taken by mouth from Day 1 to 14 of each cycle.

IP Paclitaxel

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

Related Publications (4)

• Ishigami 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)

  BACKGROUND

• Kim 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 BACKGROUND

• Ishigami 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 BACKGROUND

• Chia 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 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Wei Peng Yong, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Peng Yong, MBBS

CONTACT

(65) 6779 5555; Wei_Peng_Yong@nuhs.edu.sg

Robert Lim, MBBS

CONTACT

(65) 6779 5555; Robert_Lim@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Yong Wei Peng

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: August 1, 2018
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

SG (1)