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Feasibility Study of Intraperitoneal Paclitaxel With Oxaliplatin and Capecitabine in Patients With Advanced Gastric Cancer

Phase 2
21 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Feasibility Study of Intraperitoneal Paclitaxel With Oxaliplatin and Capecitabine in Patients With Advanced Gastric Cancer

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.

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS) rate

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Wei Peng Yong, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

January 2013

Completion Date:

November 2015

Related Keywords:

  • Gastric Cancer
  • Advanced gastric cancer
  • unresectable gastric cancer
  • recurrent gastric cancer
  • with peritoneal metastasis
  • cancer cells on peritoneal cytology
  • Stomach Neoplasms