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Alkylating agents

Temozolomide + Capecitabine for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Pamela Kunz

Research Sponsored by Eastern Cooperative Oncology Group

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for 3 years and then every 6 months for years 3-5

Awards & highlights

Study Summary

This trial tests temozolomide with or without capecitabine to treat advanced pancreatic neuroendocrine tumors to see if it is more effective.

Who is the study for?

This trial is for adults with advanced pancreatic neuroendocrine tumors who've had disease progression within the last year. They must have a life expectancy of at least 12 weeks, be able to swallow pills, and tolerate CT/MRI scans. Women of childbearing age must test negative for pregnancy and use contraception; men should also use contraception if their partner could become pregnant.Check my eligibility

What is being tested?

The study is testing whether temozolomide alone or combined with capecitabine is more effective in stopping tumor growth in patients with advanced pancreatic neuroendocrine tumors. It's a phase II trial where participants are randomly assigned to one of the two treatment groups.See study design

What are the potential side effects?

Temozolomide and capecitabine can cause nausea, vomiting, fatigue, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, and mouth sores. Some side effects might be more common when both drugs are used together.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for 3 years and then every 6 months for years 3-5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months for 3 years and then every 6 months for years 3-5

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 3 years and then every 6 months for years 3-5 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

Secondary outcome measures

Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response

Association Between Methyl Guanine Methyltransferase (MGMT) Status by Promoter Methylation and Response

Overall Survival

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (temozolomide and capecitabine)Experimental Treatment2 Interventions

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (temozolomide)Experimental Treatment1 Intervention

Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

temozolomide

2008

Completed Phase 2

~1060

capecitabine

2002

Completed Phase 3

~2360

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor

268 Previous Clinical Trials

150,686 Total Patients Enrolled

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,778 Total Patients Enrolled

1 Trials studying Glucagonoma

2 Patients Enrolled for Glucagonoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,009 Total Patients Enrolled

14 Trials studying Glucagonoma

686 Patients Enrolled for Glucagonoma

Frequently Asked Questions

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

Has capecitabine been given the green light from the U.S. Food and Drug Administration?

"Given the Phase 2 classification of capecitabine, our team at Power has ascribed it a safety rating of 2. This implies that there is some evidence for its security but no data indicating efficacy."

Answered by AI

How many participants are being admitted to the experimental program?

"At this moment, no new patients are being sought for the indicated clinical trial; it was initially published on April 11th 2013 and last updated on October 14th 2022. If you're looking to join a study related to insulinoma, 2618 trials currently need participants while 531 studies require volunteers that have been taking capecitabine."

Answered by AI

Is there any precedent for using capecitabine in clinical research?

"Presently, 531 studies are currently exploring capecitabine's efficacy with 149 in the third and final phase. Woolloongabba, Queensland is one of 16516 sites around the world that host trials for this drug."

Answered by AI

Is this research project currently open to participants?

"The information available on clinicaltrials.gov does not indicate that this trial is currently recruiting patients. Initially posted April 11th, 2013 and last updated October 14th 2022, the study has since ceased recruitment; however there are 3149 other medical studies actively seeking participants at present."

Answered by AI

How many healthcare institutions are participating in this experiment?

"100 clinical trial sites are accepting participants, such as Flower Hospital in Sylvania, Blanchard Valley Hospital in Findlay and the University of Cincinnati."

Answered by AI

Has this type of clinical trial ever been conducted before?

"Presently, there are 531 active clinical trials for capecitabine across 2291 cities and 70 countries. The pharmaceutical company Schering-Plough first initiated the drug investigation in 2002 with 60 participants; since then, 1609 studies have been conducted."

Answered by AI

What primary purposes does capecitabine serve?

"Capecitabine is a potent drug commonly used to fight the progression of diseases. Furthermore, it has been demonstrated to be effective at treating nitrosourea treatments, advanced directives, and refractory cases of mycosis fungoides."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

2013. "Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01824875.

All > Basal Cell Carcinoma > Neuroendocrine Tumor