Chemotherapy for Neuroendocrine Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new chemotherapy options for individuals with neuroendocrine cancer in the gastrointestinal tract or pancreas that has spread or cannot be surgically removed. Researchers aim to determine if the combination of temozolomide and capecitabine is more effective than standard treatments, which include cisplatin or carboplatin with etoposide. Participants must have a confirmed diagnosis of this specific cancer type and should not have received prior chemotherapy for it. Those experiencing frequent or severe symptoms from their cancer might consider joining this trial to explore potentially more effective treatment options. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any investigational agents or Coumadin while participating. Other anticoagulants are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of capecitabine and temozolomide is generally well-tolerated by patients with neuroendocrine tumors. While some side effects occur, they are usually manageable and not severe. This treatment also helps patients live longer without disease progression compared to temozolomide alone.
In contrast, using cisplatin or carboplatin with etoposide is a common approach for treating advanced neuroendocrine carcinomas. This treatment is generally considered tolerable but can cause side effects like nausea and low blood cell counts. Regular check-ups are important during treatment due to these known side effects.
Both treatment options have been used in different situations and are generally safe for patients, although individual experiences may vary. Discussing potential side effects and monitoring plans with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for neuroendocrine cancer because they offer new combinations that might enhance effectiveness. Arm A combines capecitabine and temozolomide, both oral medications, which can be more convenient and potentially less invasive than traditional IV chemotherapy options. Arm B takes a different approach by using a combination of cisplatin or carboplatin with etoposide, focusing on a robust IV regimen that has been effective in other cancers but is being explored here to see if it can better target neuroendocrine tumors. These varied approaches provide hope for improved outcomes by either offering more convenient administration or by potentially increasing the efficacy of existing drug combinations.
What evidence suggests that this trial's treatments could be effective for neuroendocrine cancer?
Research has shown that the combination of capecitabine and temozolomide, known as CAPTEM, is promising for treating neuroendocrine tumors. Studies have found that this combination can delay cancer progression and extend the lives of patients with pancreatic neuroendocrine tumors. Approximately 30% of patients experience tumor shrinkage, and 76.7% see either shrinkage or stability. Participants in this trial may receive the CAPTEM combination in Arm A.
In contrast, participants in Arm B will receive a combination of cisplatin or carboplatin with etoposide, a common treatment for neuroendocrine cancers. Research indicates that this combination has a tumor shrinkage rate of about 42.6% and offers an average survival time of around 13.6 months. Both treatments are effective, but CAPTEM may provide a longer period without cancer progression for some patients.12567Who Is on the Research Team?
Jennifer Eads
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either capecitabine and temozolomide or cisplatin/carboplatin and etoposide based on randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Carboplatin
- Cisplatin
- Etoposide
- Temozolomide
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator