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Anti-metabolites

Paclitaxel + Capecitabine for Advanced Stomach Cancer

Q: Can you elaborate on any prior research regarding Capecitabine's efficacy?

At present, the utilization of Capecitabine is being explored in 1119 active studies. Of these clinical trials, 341 are currently in Phase 3 and span over 56851 medical centres with a majority located in Guangzhou, Guangdong.

Q: To what degree is Capecitabine safe for those undergoing treatment?

Due to the Phase 2 status of Capecitabine, which indicates that there is some safety data yet no efficacy information, our team assigned a score of 2 for this drug's safety.

Q: Is it possible to join the research cohort at this time?

According to data on clinicaltrials.gov, this scientific investigation is in the process of enlisting participants. It was first listed on June 9th 2020 and last modified on October 26th 2022.

Q: How many individuals have enrolled in this research endeavor?

Affirmative. According to the details published on clinicaltrials.gov, this medical research was posted June 9th 2020 and last updated October 26th 2022. The team is looking for a total of 74 individuals across one site.

Q: What illness does Capecitabine usually combat?

Patients afflicted with locally advanced non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> often receive capecitabine as a form of treatment. This medication is also used to manage metastatic <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a>, and advanced thymoma in some cases.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first treatment until death, an average of 1.5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

My cancer is confirmed as gastric adenocarcinoma or Siewert III gastroesophageal junction adenocarcinoma.

Select...

My blood counts and liver/kidney functions are within normal ranges.

Select...

I am physically fit for surgery and chemotherapy.

Select...

I have signs of cancer spread in my abdomen found through imaging or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first treatment until death, an average of 1.5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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 2020 Phase 2 & 3 trial • 151 Patients • NCT03093870

63%

Nausea

58%

Fatigue

54%

Diarrhoea

50%

Decreased Appetite

46%

Vomiting

42%

Pyrexia

42%

Hypokalaemia

38%

Abdominal Pain

33%

Constipation

33%

Blood Bilirubin Increased

29%

Abdominal Distension

29%

Hyponatraemia

29%

Dizziness

29%

Oedema Peripheral

29%

Back Pain

25%

Hypotension

25%

Stomatitis

25%

Palmar-plantar Erythrodysaethesia Syndrome

25%

Dehydration

25%

Anaemia

21%

Aspartate Aminotransferase Increased

21%

Dyspnoea

21%

Chills

21%

Dyspepsia

21%

Asthenia

21%

Proteinuria

17%

Platelet Count Decreased

17%

Alanine Aminotransferase Increased

17%

Rash

17%

Ascites

13%

Hyperbilirubinaemia

13%

Cough

13%

Abdominal Pain Upper

13%

Blood Creatinine Increased

13%

Hypomagnesaemia

13%

Dry mouth

13%

Dyspnoea exertional

13%

Weight Decreased

13%

Hypoalbuminaemia

13%

Muscular weakness

13%

Urinary tract infection

Depression

Gastrooesophageal Reflux Disease

Gamma-glutamyltransferase increased

International normalised ratio increased

Paraesthesia

Influenza like illness

Dysphonia

Malaise

Hypoaesthesia

Faeces discolored

Hypoglycemia

Acute Kidney Injury

Enterocolitis

Hematemesis

Hyperkalaemia

Hypocalcaemia

Blood alkaline phosphatase increased

Epistaxis

Bile duct obstruction

Oral pain

Neutrophil Count Decreased

Myalgia

Insomnia

Early satiety

Rhinitis allergic

Bursitis

Musculoskeletal pain

Anxiety

Dysgeusia

Acute kidney injury

Cholangitis

Cardiac arrest

Rash generalized

Respiratory Failure

Septic shock

Small intestinal obstruction

Spinal cord compression

Toxic leukoencephalopathy

Peripheral Sensory Neuropathy

Haematemesis

Hypercalcaemia

Hyponatremia

Hypoxic-ischaemic encephalopathy

Ischaemic stroke

Lung Infection

Metabolic acidosis

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Placebo and Capecitabine - Part 1

Varlitinib and Capecitabine - Safety Lead-In

Varlitinib and Capecitabine - Part 1

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

Capecitabine

2013

Completed Phase 3

~3420

Paclitaxel

2011

Completed Phase 4

~5380

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,260 Total Patients Enrolled

Jeremy L Davis, M.D.Principal InvestigatorNational Cancer Institute (NCI)

8 Previous Clinical Trials

3,307 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you elaborate on any prior research regarding Capecitabine's efficacy?

"At present, the utilization of Capecitabine is being explored in 1119 active studies. Of these clinical trials, 341 are currently in Phase 3 and span over 56851 medical centres with a majority located in Guangzhou, Guangdong."

Answered by AI

To what degree is Capecitabine safe for those undergoing treatment?

"Due to the Phase 2 status of Capecitabine, which indicates that there is some safety data yet no efficacy information, our team assigned a score of 2 for this drug's safety."

Answered by AI

Is it possible to join the research cohort at this time?

"According to data on clinicaltrials.gov, this scientific investigation is in the process of enlisting participants. It was first listed on June 9th 2020 and last modified on October 26th 2022."

Answered by AI

How many individuals have enrolled in this research endeavor?

"Affirmative. According to the details published on clinicaltrials.gov, this medical research was posted June 9th 2020 and last updated October 26th 2022. The team is looking for a total of 74 individuals across one site."

Answered by AI

What illness does Capecitabine usually combat?

"Patients afflicted with locally advanced non-small cell lung cancer often receive capecitabine as a form of treatment. This medication is also used to manage metastatic bladder cancer, AIDS, and advanced thymoma in some cases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

Jeremy Davis, M.D. 2020. "Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04034251.

All > Peritoneal Carcinomatosis