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Anti-metabolites

Paclitaxel + Capecitabine for Advanced Stomach Cancer

Phase 2
Waitlist Available
Led By Jeremy L Davis, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status <=1
Patients must have histologically or cytologically confirmed gastric adenocarcinoma, including Siewert III gastroesophageal junction adenocarcinoma, confirmed by the NCI Laboratory of Pathology, and have provided a block or unstained slides of primary or metastatic tumor tissue or newly obtained fresh biopsy of a tumor lesion in case archival tissue sample is not available.
Must not have
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.
Disseminated extra-peritoneal or solid organ metastases: Excludes greater omentum and ovarian metastases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first treatment until death, an average of 1.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to treat stomach cancer that has spread throughout the belly.

Who is the study for?
Adults over 18 with advanced stomach cancer that has spread within the belly are eligible. They must be physically able to undergo laparoscopy and chemotherapy, have not had certain prior treatments that failed or caused severe side effects, and their major organs must function well. Pregnant women can't join, nor can those with specific allergies or uncontrolled illnesses.
What is being tested?
The trial tests a combination of paclitaxel (administered through an abdominal port and arm vein) and oral capecitabine in patients with gastric adenocarcinoma. The goal is to see if this treatment method improves survival rates and delays cancer growth compared to current methods.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used, nerve damage (neuropathy), blood disorders like low white cell count which increases infection risk, fatigue from anemia due to low red cell count, digestive issues such as nausea or diarrhea from capecitabine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.
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My cancer is confirmed as gastric adenocarcinoma or Siewert III gastroesophageal junction adenocarcinoma.
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My blood counts and liver/kidney functions are within normal ranges.
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I am physically fit for surgery and chemotherapy.
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I have signs of cancer spread in my abdomen found through imaging or surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that could interfere with the study.
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My cancer has spread to solid organs but not to the greater omentum or ovaries.
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I have a history of dihydropyrimidine dehydrogenase deficiency.
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I have had surgery or chemotherapy in my abdomen to reduce cancer.
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I am allergic to medications similar to Paclitaxel, Capecitabine, or others used in this study.
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I am not pregnant or breastfeeding.
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I have signs or symptoms of a blockage in my intestines caused by cancer.
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I have severe nerve damage in my hands or feet.
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My cancer progressed despite treatment with paclitaxel or nab-paclitaxel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first treatment until death, an average of 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first treatment until death, an average of 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy
Secondary study objectives
Frequency of Objective Histopathologic Response to Therapy
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval
Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval
+4 more
Other study objectives
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
73%
Palmar-plantar erythrodysesthesia syndrome
58%
Fatigue
56%
Diarrhea
38%
Hypertension
38%
Nausea
30%
Mucositis
29%
Vomiting
26%
Weight loss
26%
Weight gain
24%
Anorexia
20%
Nail disorder
17%
Back pain
16%
Hypothermia
15%
Constipation
15%
Abdominal pain
14%
Neutrophil count decreased
13%
Dizziness
13%
Upper respiratory infection
13%
Headache
11%
Dyspepsia
10%
Fever
10%
Obesity
10%
Dysgeusia
10%
Pain in extremity
9%
Arthralgia
9%
Bone pain
9%
Anemia
8%
Cough
8%
Pruritus
7%
Flu like symptoms
6%
Pain
4%
Alopecia
2%
Thromboembolic event
2%
Bone fracture
1%
Gastrointestinal infection
1%
Spinal cord compression
1%
Febrile neutropenia
1%
Hot flashes
1%
Pancreatitis
1%
Respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
Cohort 2: Palbociclib Plus Fulvestrant

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice DailyExperimental Treatment3 Interventions
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
Group II: Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice DailyExperimental Treatment3 Interventions
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
Group III: Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice DailyExperimental Treatment3 Interventions
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BardPort Titanium Implanted Port with Peritoneal Catheter
2020
Completed Phase 2
~20
Capecitabine
2013
Completed Phase 3
~4280
Paclitaxel
2011
Completed Phase 4
~5450

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,568 Total Patients Enrolled
Jeremy L Davis, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
2,774 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04034251 — Phase 2
Stomach Cancer Research Study Groups: Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily, Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily, Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily
Stomach Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04034251 — Phase 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04034251 — Phase 2
~2 spots leftby Jan 2026
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