Study on Temozolomide With or Without Capecitabine for Treating Advanced Pancreatic Neuroendocrine Tumors
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT01824875
This clinical trial is testing whether the chemotherapy drug temozolomide, used alone or with another drug called capecitabine, is effective in treating advanced pancreatic neuroendocrine tumors. The study aims to find out which combination works better in stopping tumor growth.
Patient Parameters
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Program Overview
This study is exploring how well the chemotherapy drug temozolomide works on its own or when combined with capecitabine in treating advanced pancreatic neuroendocrine tumors. These drugs aim to stop tumor cells from growing by killing them or preventing them from dividing and spreading. Researchers want to determine if using temozolomide with capecitabine is more effective than using temozolomide alone.
Description
The main goal of this study is to see how long patients can live without their cancer getting worse when treated with either temozolomide alone or with both temozolomide and capecitabine. Researchers will also look at how many patients respond to the treatment, how long they live overall, and any side effects they experience. Additionally, the study will investigate if a specific protein in the tumors can predict how well patients respond to the treatment.
Participants will be randomly assigned to one of two groups:
- Group A: Will take temozolomide by mouth once a day for five days in a row, repeating this cycle every 28 days for up to 13 cycles, unless the cancer worsens or side effects become too severe.
- Group B: Will take capecitabine by mouth twice a day for 14 days and temozolomide once a day from days 10 to 14, repeating this cycle every 28 days for up to 13 cycles, unless the cancer worsens or side effects become too severe.
After finishing the treatment, participants will have follow-up visits every three months for two years, then every six months for three more years.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of advanced pancreatic neuroendocrine tumor that cannot be surgically removed or has spread.
- Must have measurable tumors based on specific medical criteria.
- The cancer must have progressed within the last 12 months.
- Previous treatment with everolimus or sunitinib is allowed if stopped at least four weeks before joining the study.
- Can continue using somatostatin analogues if on a stable dose for eight weeks and the cancer has progressed.
- Must meet specific blood count and organ function requirements.
- Must be able to swallow pills and undergo necessary imaging tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
- Men must agree to use contraception or abstain from sex during the study.
Exclusion Criteria
- Cannot have small cell carcinoma.
- Cannot have had previous treatment with temozolomide, dacarbazine, capecitabine, or 5-FU.
- Cannot be taking other experimental drugs during the study.
- Cannot be on Coumadin, but other blood thinners are allowed.
- Cannot have cancer that has spread to the brain or spinal cord.
- Cannot have uncontrolled infections or serious medical or psychiatric conditions.
- Cannot have allergies to similar drugs as temozolomide or capecitabine.
- Cannot have absorption issues that affect drug intake.
- Cannot have had certain heart conditions within the last year.
- Cannot have other cancers unless they meet specific conditions.
- Cannot be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Kaiser Anaheim Medical Center | 92807 | Anaheim | California |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| Kaiser Permanente Medical Group - Baldwin Park | 91706 | Baldwin Park | California |
| Kaiser Foundation Hospital | 90706 | Bellflower | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Mills - Peninsula Hospitals | 94010 | Burlingame | California |
| Kaiser Permanente Hospital | 92335 | Fontana | California |
| Kaiser Permanente, Fremont | 94538 | Fremont | California |
| Kaiser Permanente | 93720 | Fresno | California |
| Kaiser Permanente - Harbor City | 90710 | Harbor City | California |
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