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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 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
OS
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%
Blood Bilirubin Increased
33%
Constipation
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%
Chills
21%
Dyspnoea
21%
Aspartate Aminotransferase Increased
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Blood Creatinine Increased
13%
Cough
13%
Hypomagnesaemia
13%
Hyperbilirubinaemia
13%
Abdominal Pain Upper
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Hypoaesthesia
8%
Influenza like illness
8%
Gamma-glutamyltransferase increased
8%
Paraesthesia
8%
Dysphonia
8%
Malaise
8%
Faeces discolored
8%
International normalised ratio increased
8%
Gastrooesophageal Reflux Disease
8%
Depression
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Blood alkaline phosphatase increased
8%
Epistaxis
8%
Bile duct obstruction
8%
Oral pain
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Rhinitis allergic
8%
Bursitis
8%
Musculoskeletal pain
8%
Anxiety
8%
Dysgeusia
8%
Acute kidney injury
8%
Cholangitis
4%
Cardiac arrest
4%
Rash generalized
4%
Respiratory Failure
4%
Septic shock
4%
Small intestinal obstruction
4%
Spinal cord compression
4%
Toxic leukoencephalopathy
4%
Peripheral Sensory Neuropathy
4%
Haematemesis
4%
Hypercalcaemia
4%
Hyponatremia
4%
Hypoxic-ischaemic encephalopathy
4%
Ischaemic stroke
4%
Lung Infection
4%
Metabolic acidosis
4%
Aspiration
100%
80%
60%
40%
20%
0%
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Temozolomide and Capecitabine are common treatments for Intestinal Carcinoma due to their specific mechanisms of action. Temozolomide is an alkylating agent that damages DNA, leading to cancer cell death. Capecitabine is a prodrug that is metabolized into 5-fluorouracil (5-FU), which inhibits DNA synthesis by targeting thymidylate synthase. These mechanisms are crucial as they directly interfere with the cancer cells' ability to replicate and survive, providing a targeted approach to treatment that can improve patient outcomes.

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
13,734 Previous Clinical Trials
40,967,537 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
~4 spots leftby Jan 2025