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Capecitabine for Pancreatic Neuroendocrine Tumors

Katmai Oncology Group, Anchorage, AK
Pancreatic Neuroendocrine Tumors+4 More ConditionsCapecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at giving capecitabine & temozolomide after surgery to patients with a certain kind of pancreatic tumor. These drugs work in different ways to stop the growth of tumor cells. This could prevent or delay the return of cancer in these patients.

Eligible Conditions
  • Stage II Pancreatic Neuroendocrine Tumor
  • Liver Cancer
  • Stage III Pancreatic Neuroendocrine Tumor
  • Stage I Pancreatic Neuroendocrine Tumor
  • Pancreatic Neuroendocrine Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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177Lu-DOTATATE
1
Capecitabine
1
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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From date of registration to date of death due to any cause, assessed up to 5 years

Year 5
Recurrence-free survival (RFS)
Year 5
Overall survival (OS)
Day 30
Incidence of adverse events

Trial Safety

Phase-Based Safety

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

Similar Trials

1
177Lu-DOTATATE
1
Capecitabine
1
Triapine

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%Hypoglycemia
5%Abdominal Pain Upper
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%International normalised ratio increased
2%Jaundice cholestatic
2%Hypomagnesaemia
2%Small intestinal haemorrhage
2%Pain
2%Dry mouth
2%Oral pain
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%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Arm II (surveillance)
1 of 2
Arm I (capecitabine, temozolomide)
1 of 2

Active Control

Experimental Treatment

141 Total Participants · 2 Treatment Groups

Primary Treatment: Capecitabine · No Placebo Group · Phase 2

Arm I (capecitabine, temozolomide)Experimental Group · 2 Interventions: Temozolomide, Capecitabine · Intervention Types: Drug, Drug
Arm II (surveillance)NoIntervention Group · 1 Intervention: Arm II (surveillance) · Intervention Types:
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: from date of registration to date of death due to any cause, assessed up to 5 years

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
388 Previous Clinical Trials
262,460 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,460 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,275 Previous Clinical Trials
41,234,671 Total Patients Enrolled
Heloisa P SoaresPrincipal InvestigatorSWOG Cancer Research Network

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had surgery or other procedures to remove up to five liver metastases that were caused by a well-differentiated pancreatic neuroendocrine tumor.
You must be able to take pills by swallowing them.
You cannot have another active cancer or any history of cancer, except for a few specific types that have been treated and are no longer present or have been in remission for at least two years.
References

Frequently Asked Questions

Are there any available slots for new patients in this research project?

"This study is currently recruiting participants, as indicated on clinicaltrials.gov. The trial was originally posted on October 14th, 2021 and was last updated on December 3rd, 2021." - Anonymous Online Contributor

Unverified Answer

Are there potentially fatal side effects to taking Capecitabine?

"While there is some data suggesting capecitabine is safe, as this is only a Phase 2 trial, there is no clinical evidence yet to support its efficacy. Consequently, it received a score of 2." - Anonymous Online Contributor

Unverified Answer

What are some other research projects that have used Capecitabine?

"As of now, there are 561 total trials regarding Capecitabine with 153 being in the third stage. Although many studies for this treatment are based in Woolloongabba, Queensland, there are a whopping 16764 locations running clinical trials for it." - Anonymous Online Contributor

Unverified Answer

How many people can join this research project?

"That is correct. The clinical trial, which began recruitment on October 14th 2021, is still looking for patients. There have been no changes to the 6 participating sites or the 141 patient goal since December 3rd 2021." - Anonymous Online Contributor

Unverified Answer

For what purpose is Capecitabine most often prescribed?

"Capecitabine is a medication that can be used to manage progression, disease. It has also been shown to help patients with nitrosourea treatment, advance directives, and refractory, advanced mycosis fungoides." - Anonymous Online Contributor

Unverified Answer

Is this an innovative clinical trial?

"There are 561 ongoing studies for the medication Capecitabine in 70 different countries. The first study was held 18 years ago and involved 60 patients. It completed Phase 2 of testing in 2002 and was sponsored by Schering-Plough. Since that time, 843 total studies have been completed." - Anonymous Online Contributor

Unverified Answer

At how many hospitals is this research being conducted?

"There are six medical centers participating in this study, located in Ames, Fort Dodge, Boone, and other cities." - 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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