67 Participants Needed

Chemotherapy for Neuroendocrine Cancer

Recruiting at 703 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ECOG-ACRIN Cancer Research Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

What data supports the effectiveness of the drug combination of capecitabine and temozolomide for neuroendocrine cancer?

Research shows that the combination of capecitabine and temozolomide is promising for treating well-differentiated neuroendocrine tumors, with manageable side effects and improved outcomes. In patients with metastatic pancreatic endocrine carcinomas, this combination has shown synergistic effects, enhancing the treatment's effectiveness.12345

Is chemotherapy with temozolomide and capecitabine safe for treating neuroendocrine cancer?

Temozolomide and capecitabine have been used in treating neuroendocrine tumors, but significant treatment-related toxicity (side effects) has been reported. This means while they can be effective, they may also cause notable side effects in some patients.13567

What makes the chemotherapy treatment for neuroendocrine cancer unique?

This treatment is unique because it combines capecitabine and temozolomide, which are taken orally, offering a more convenient option compared to traditional intravenous chemotherapy. This combination has shown promising results with manageable side effects, especially for well-differentiated neuroendocrine tumors, which are typically resistant to other chemotherapy options.12478

What is the purpose of this trial?

This trial is testing two different sets of cancer drugs to see which works better for patients with advanced neuroendocrine carcinoma that has spread or cannot be removed by surgery. The drugs aim to stop cancer from growing and spreading by attacking the cancer cells in different ways. One of the drugs being tested is used for treating advanced neuroendocrine tumors.

Research Team

JE

Jennifer Eads

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

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

The cells in your sample show rapid growth, or there are a lot of dividing cells in the sample.
My cancer's size can be measured and was checked by CT or MRI within the last 4 weeks.
I can take care of myself and am up and about more than half of my waking hours.
See 28 more

Exclusion Criteria

I am allergic to certain chemotherapy drugs like cisplatin or carboplatin.
I do not have serious heart issues, unstable chest pain, irregular heartbeats, or major psychiatric/social situations that would prevent me from following the study's requirements.
I have no other cancers, except for certain allowed types.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either capecitabine and temozolomide or cisplatin/carboplatin and etoposide based on randomization

Up to 1 year
Courses repeat every 21-28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for 2 years, then every 6 months for 3 years

Treatment Details

Interventions

  • Capecitabine
  • Carboplatin
  • Cisplatin
  • Etoposide
  • Temozolomide
Trial Overview The trial compares two chemotherapy regimens: temozolomide plus capecitabine versus cisplatin or carboplatin with etoposide. It aims to determine which combination is more effective against certain types of neuroendocrine carcinomas that haven't responded well to standard treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (capecitabine, temozolomide)Experimental Treatment3 Interventions
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (cisplatin, carboplatin, etoposide)Active Control4 Interventions
Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Xeloda for:
  • Colorectal cancer
  • Breast cancer
🇺🇸
Approved in United States as Xeloda for:
  • Colorectal cancer
  • Breast cancer
🇨🇦
Approved in Canada as Xeloda for:
  • Colorectal cancer
  • Breast cancer
🇯🇵
Approved in Japan as Xeloda for:
  • Colorectal cancer
  • Breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials
122
Recruited
160,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 65 patients with grade 1/2 neuroendocrine tumors, capecitabine and temozolomide chemotherapy resulted in a response rate of 47.7%, with a median progression-free survival of 16.1 months and overall survival of 38.3 months.
The treatment was generally well-tolerated, with only 13.8% of patients experiencing severe toxicities, indicating that this chemotherapy combination is a promising option for managing both pancreatic and non-pancreatic neuroendocrine tumors.
Capecitabine and temozolomide in grade 1/2 neuroendocrine tumors: a Spanish multicenter experience.Crespo, G., Jiménez-Fonseca, P., Custodio, A., et al.[2018]
In a study of 30 patients with metastatic pancreatic endocrine carcinomas, the combination of capecitabine and temozolomide resulted in a remarkable 70% objective response rate and a median progression-free survival of 18 months.
The treatment showed a high two-year survival rate of 92% with only 12% of patients experiencing severe adverse events, indicating a favorable safety profile compared to traditional therapies.
First-line chemotherapy with capecitabine and temozolomide in patients with metastatic pancreatic endocrine carcinomas.Strosberg, JR., Fine, RL., Choi, J., et al.[2022]
In a phase II trial involving 78 patients with advanced poorly differentiated neuroendocrine carcinomas, the chemotherapy regimen of paclitaxel, carboplatin, and etoposide resulted in a 53% major response rate, with 15% achieving complete responses and some remaining disease-free for up to 66 months.
The treatment demonstrated moderate toxicity, primarily myelosuppression, and showed no significant efficacy advantages over standard platinum/etoposide regimens, suggesting that similar treatment strategies used for small-cell lung cancer may be appropriate for these patients.
Phase II trial of paclitaxel, carboplatin, and etoposide in advanced poorly differentiated neuroendocrine carcinoma: a Minnie Pearl Cancer Research Network Study.Hainsworth, JD., Spigel, DR., Litchy, S., et al.[2015]

References

Capecitabine and temozolomide in grade 1/2 neuroendocrine tumors: a Spanish multicenter experience. [2018]
Profile of capecitabine/temozolomide combination in the treatment of well-differentiated neuroendocrine tumors. [2020]
First-line chemotherapy with capecitabine and temozolomide in patients with metastatic pancreatic endocrine carcinomas. [2022]
Phase II study of temozolomide and thalidomide in patients with metastatic neuroendocrine tumors. [2022]
Temozolomide alone or in combination with capecitabine in patients with advanced neuroendocrine neoplasms: an Italian multicenter real-world analysis. [2021]
Safety and Activity of Metronomic Temozolomide in Second-Line Treatment of Advanced Neuroendocrine Neoplasms. [2020]
Safety and Efficacy of the S-1/Temozolomide Regimen in Patients with Metastatic Neuroendocrine Tumors. [2019]
Phase II trial of paclitaxel, carboplatin, and etoposide in advanced poorly differentiated neuroendocrine carcinoma: a Minnie Pearl Cancer Research Network Study. [2015]
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