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Capecitabine for Intestinal Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Jewish Hospital Medical Center Northeast, Louisville, KYIntestinal Carcinoma+2 MoreCapecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is studying temozolomide and capecitabine to see how well they work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas.

Eligible Conditions
  • Intestinal Neuroendocrine Carcinoma
  • Pancreatic Neuroendocrine Tumor
  • Gastric Neuroendocrine Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Capecitabine
1
Osimertinib
1
Cisplatin

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Baseline
Ki-67 as a continuous measure assessed by immunohistochemistry (IHC)
Ki-67 measured centrally
Ki-67 measured with registering institutions? pathology assessments
Optimal cutoff value in Ki-67 that defines patients with prolonged OS assessed by IHC
Prognostic significance of poorly differentiated non-small cell gastroenteropancreatic neuroendocrine tumors
Prognostic significance of well differentiated non-small cell gastroenteropancreatic neuroendocrine tumors
Year 5
OS
Year 1
PFS
Day 30
Incidence of toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Up to 5 years
Response rate (complete response or partial response) by RECIST 1.1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Capecitabine
1
Osimertinib
2
Cisplatin

Side Effects for

Varlitinib and Capecitabine - Part 1
52%Nausea
44%Blood Bilirubin Increased
41%Diarrhoea
39%Decreased Appetite
34%Vomiting
31%Palmar-plantar Erythrodysaethesia Syndrome
25%Abdominal Pain
25%Fatigue
23%Pyrexia
23%Blood Creatinine Increased
20%Anaemia
17%Asthenia
17%Pruritus
16%Alanine Aminotransferase Increased
14%Constipation
14%Aspartate Aminotransferase Increased
13%Malaise
13%Platelet Count Decreased
13%Rash
11%Stomatitis
11%Dyspepsia
11%Hyperbilirubinaemia
9%Hypoalbuminaemia
9%Chills
8%Dysgeusia
8%Mucosal Inflammation
8%Dyspnoea
8%Cholangitis
8%Pneumonia
8%Peripheral Sensory Neuropathy
8%Acute Kidney Injury
8%Skin Hyperpigmentation
8%Blood bilirubin increased
6%Back Pain
6%Hyponatraemia
6%Abdominal Distension
6%Hypotension
6%Oedema Peripheral
6%Cough
6%Dizziness
5%Abdominal Pain Upper
5%Hypoglycemia
5%Gastrooesophageal Reflux Disease
5%Neutrophil Count Decreased
5%Weight Decreased
5%Insomnia
5%Proteinuria
5%Myalgia
5%Ascites
3%Hyperkalaemia
3%Bile duct obstruction
3%Disease progression
3%Hypokalaemia
3%Musculoskeletal pain
3%Hypocalcaemia
3%Epistaxis
3%Acute kidney injury
3%Blood alkaline phosphatase increased
2%Jaundice cholestatic
2%Hypomagnesaemia
2%Small intestinal haemorrhage
2%Pain
2%Dry mouth
2%Oral pain
2%International normalised ratio increased
2%Hepatobiliary infection
2%Anemia
2%Decreased appetite
2%Blood creatinine increased
2%Erythema multiforme
2%Biliary sepsis
2%Biliary tract infection
2%Intestinal obstruction
2%Cholangiolitis
2%Liver abscess
2%Biloma
2%Gamma-glutamyltransferase increased
2%Paraesthesia
2%Muscular weakness
2%Oedema peripheral
2%Cholecystitis
2%Jaundice
2%General physical health deterioration
2%Urinary tract infection
2%Dyspnoea exertional
2%Blood culture positive
2%Anxiety
This histogram enumerates side effects from a completed 2020 Phase 2 & 3 trial (NCT03093870) in the Varlitinib and Capecitabine - Part 1 ARM group. Side effects include: Nausea with 52%, Blood Bilirubin Increased with 44%, Diarrhoea with 41%, Decreased Appetite with 39%, Vomiting with 34%.

Trial Design

2 Treatment Groups

Arm B (cisplatin, carboplatin, etoposide)
1 of 2
Arm A (capecitabine, temozolomide)
1 of 2

Active Control

Experimental Treatment

126 Total Participants · 2 Treatment Groups

Primary Treatment: Capecitabine · No Placebo Group · Phase 2

Arm A (capecitabine, temozolomide)Experimental Group · 3 Interventions: Laboratory Biomarker Analysis, Temozolomide, Capecitabine · Intervention Types: Other, Drug, Drug
Arm B (cisplatin, carboplatin, etoposide)ActiveComparator Group · 4 Interventions: Etoposide, Laboratory Biomarker Analysis, Carboplatin, Cisplatin · Intervention Types: Drug, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Capecitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
108 Previous Clinical Trials
173,309 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,165 Previous Clinical Trials
41,167,315 Total Patients Enrolled
Jennifer EadsPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
1 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 34 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to swallow pills.
You cannot take Coumadin (a blood thinner) while on this treatment, but other blood thinners may be allowed.
You cannot have any health conditions that stop your body from properly absorbing the study medication.
References

Frequently Asked Questions

To what extent can Capecitabine prove to be harmful for patients?

"Our research team at Power has rated the safety of Capecitabine a 2, as it is only in Phase 2 where there are some findings that back up its security but not yet any evidence for its efficacy." - Anonymous Online Contributor

Unverified Answer

How many individuals have been recruited to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov records confirm that this medical trial, which was first published on November 6th 2015, is currently recruiting patients. 126 volunteers must be sourced from 24 distinct clinical sites." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor still accepting participants?

"Indeed, the details publicized on clinicaltrials.gov attest to this research project still searching for participants. This trial was first posted in November of 2015 and last updated in July of 2022 with a target enrollment number of 126 people at 24 sites." - Anonymous Online Contributor

Unverified Answer

Have any other experiments utilized Capecitabine for research purposes?

"At present, there are 1745 trials in progress for Capecitabine. 538 of these live studies have reached Phase 3 status. While many clinical sites that host this research can be found in Guangzhou, Guangdong, 83186 different locations worldwide are currently conducting experiments with the medication." - Anonymous Online Contributor

Unverified Answer

What is the scope of locations where this trial is operational?

"Currently, 24 medical sites are enrolling patients for this trial, including 21st Century Oncology-Fort Apache in Las Vegas, Saint Mary Mercy Hospital in Livonia and University of Cincinnati/Barrett Cancer Center in Cincinnati. There is an additional selection of research centres scattered across the United States." - Anonymous Online Contributor

Unverified Answer

What clinical applications is Capecitabine most often used to manage?

"Capecitabine is an effective therapy for refractory Ewing sarcoma, Merkel cell cancer, and initial treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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