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Feasibility Study of Intraperitoneal Paclitaxel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739894
Recruitment Status : Unknown
Verified June 2016 by Haematology-Oncology, National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : December 4, 2012
Last Update Posted : June 7, 2016
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: IP Paclitaxel Phase 2

Detailed Description:

The median survival of patients with unresectable gastric cancer treated with systemic chemotherapy is about 12 months. In patients with histologically proven unresectable or recurrent gastric cancer limited to the peritoneum and/or cancer cells in peritoneal cytology, the combination of i.p. paclitaxel with systemic chemotherapy reported a median survival time of 23.6 months. The peritoneal cytology turned negative for 86% of patients. In an updated report, gastrectomy was performed on 52 patients after disappearance or obvious shrinkage of peritoneal metastasis. In this cohort, the median survival time (MST) was 34.9 months. A phase III trial (PHOENIX-GC trial (Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis )) comparing intraperitoneal(IP) regimen with systemic chemotherapy versus systemic therapy alone is currently opened for recruitment in Japan.

The multidisciplinary treatment combining IP-containing chemotherapy and surgery was found to be safe and effective for gastric cancer patients with peritoneal metastasis. A phase I study combining i.p. paclitaxel with oxaliplatin and S-1, found no dose limiting toxicity in all dose levels. Grade 3 neutropenia was observed in one patient at recommended phase 2 dose (RP2D) of i.p. paclitaxel of 40 mg/m2. In addition, grade 2 non-hematological toxicities observed were anorexia (n=6/12), fatigue (n=4/12) and nausea (n=2/12).

Both S-1 and capecitabine are orally available fluoropyrimidine. When combined with oxaliplatin, both S-1 and capecitabine were found to be equally active and well tolerated in advanced gastric cancer patients. As S-1 is not yet widely available worldwide, the combination of capecitabine and a platinum chemotherapy is still one of the most commonly adopted chemotherapy regimen for patients with advanced gastric cancer. In this study, we intend to assess the efficacy and feasibility of combining weekly i.p. paclitaxel with oxaliplatin and capecitabine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Intraperitoneal Paclitaxel With Oxaliplatin and Capecitabine in Patients With Advanced Gastric Cancer
Study Start Date : January 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: IP Paclitaxel
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
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.

Primary Outcome Measures :
  1. Overall survival (OS) rate [ Time Frame: 1 year ]
    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 Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 3-weekly ]
    Toxicity will be monitored 3-weekly and graded according to the National Cancer Institute —Common Terminology Criteria for Adverse Events version 4.0.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01739894

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Contact: Wei Peng Yong, MBBS (65) 6779 5555
Contact: Robert Lim, MBBS (65) 6779 5555

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National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Wei Peng Yong, MBBS    (65) 6779 5555   
Contact: Maricel Cordero    (65) 6772 2612   
Principal Investigator: Wei Peng Yong, MBBS         
Sponsors and Collaborators
National University Hospital, Singapore
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Principal Investigator: Wei Peng Yong, MBBS National University Hospital, Singapore

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Responsible Party: Haematology-Oncology, Dr. Yong Wei Peng, National University Hospital, Singapore Identifier: NCT01739894    
Other Study ID Numbers: GA01/12/12
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Keywords provided by Haematology-Oncology, National University Hospital, Singapore:
Advanced gastric cancer
unresectable gastric cancer
recurrent gastric cancer
with peritoneal metastasis
cancer cells on peritoneal cytology
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic