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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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