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Anti-metabolites

Chemotherapy for Neuroendocrine Cancer

Phase 2

Waitlist Available

Led By Jennifer Eads

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

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.

Who is the study for?

This trial is for adults with advanced, inoperable or metastatic neuroendocrine carcinoma of the gastrointestinal tract or pancreas. They should not have had prior systemic treatment for this cancer and must be physically well enough to participate (ECOG 0-2). Participants need functioning major organs, no severe allergies to study drugs, no other cancers unless specific conditions are met, and cannot be pregnant. Effective contraception is advised.Check my eligibility

What is being tested?

The trial compares two chemotherapy regimens: temozolomide plus capecitabine versus cisplatin or carboplatin with etoposide. It aims to determine which combination is more effective against certain types of neuroendocrine carcinomas that haven't responded well to standard treatments.See study design

What are the potential side effects?

Possible side effects include nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk and bleeding problems, liver and kidney function changes. Rarely there may be allergic reactions or hand-foot syndrome where hands or feet become swollen and painful.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My kidney function tests are within normal limits.

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I do not have any serious infections, heart issues, or mental health conditions that would prevent me from following the study's requirements.

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I have no allergies to specific cancer drugs like cisplatin or carboplatin.

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I haven't had a heart attack, unstable angina, or blood clots in my arteries in the last year.

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I do not have problems absorbing medications.

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I am not taking Coumadin but may be on other blood thinners.

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My cancer is confirmed as non-small cell lung cancer through a biopsy.

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I do not have a known DPD deficiency.

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My cancer is a type that started in my stomach or pancreas and cannot be surgically removed.

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I do not have symptoms from peripheral vascular disease.

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I am not pregnant or breast-feeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

PFS

Secondary outcome measures

Incidence of toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Response rate (complete response or partial response) by RECIST 1.1

Other outcome measures

Ki-67 as a continuous measure assessed by immunohistochemistry (IHC)

Ki-67 measured centrally

Ki-67 measured with registering institutions? pathology assessments

+3 more

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (capecitabine, temozolomide)Experimental Treatment3 Interventions

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (cisplatin, carboplatin, etoposide)Active Control4 Interventions

Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1930

Capecitabine

2013

Completed Phase 3

~3420

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,855 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,086 Total Patients Enrolled

Jennifer EadsPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

1 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02595424 — Phase 2

Intestinal Carcinoma Research Study Groups: Arm A (capecitabine, temozolomide), Arm B (cisplatin, carboplatin, etoposide)

Intestinal Carcinoma Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT02595424 — Phase 2

Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02595424 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI