Study Comparing Two Chemotherapy Combinations for Advanced Gastrointestinal Neuroendocrine Carcinomas
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT02595424
This clinical trial is comparing two different chemotherapy combinations to see which works better for treating advanced neuroendocrine carcinomas of the gastrointestinal tract or pancreas that cannot be surgically removed or have spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if the combination of temozolomide and capecitabine is more effective than the standard treatment of cisplatin or carboplatin with etoposide for patients with advanced neuroendocrine carcinoma of the gastrointestinal tract or pancreas. These drugs work by stopping cancer cells from growing, dividing, or spreading. Researchers want to see if the new combination can improve outcomes for patients with this type of cancer.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when treated with either the standard chemotherapy (cisplatin or carboplatin and etoposide) or the new combination (temozolomide and capecitabine). Researchers will also look at how well each treatment shrinks tumors and how long patients live overall. They will monitor any side effects from the treatments.
Patients will be randomly assigned to one of two groups:
- Group A: Patients will take capecitabine pills twice a day for 14 days and temozolomide pills once a day for 5 days, repeating every 28 days unless the cancer progresses or side effects become too severe.
- Group B: Patients will receive cisplatin or carboplatin through an IV for 1-3 days and etoposide through an IV for 1-3 days, repeating every 21 days unless the cancer progresses or side effects become too severe.
After finishing the treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 more years.
Eligibility Criteria
Inclusion Criteria
- Have advanced neuroendocrine carcinoma of the gastrointestinal tract or pancreas that cannot be removed by surgery or has spread.
- Have a specific type of tumor confirmed by lab tests.
- Have a tumor growth rate (Ki-67 index) between 20-100% or at least 10 dividing cells per 10 high-powered fields.
- Have measurable disease based on specific imaging criteria.
- Have completed any prior surgeries at least 4 weeks before starting the study.
- Be in good overall health with an ECOG performance status of 0-2.
- Not be taking any other investigational drugs or Coumadin during the study.
- Have adequate blood cell counts and organ function based on lab tests.
- Have a life expectancy of at least 12 weeks.
- Be able to swallow pills and undergo required imaging tests.
- Women of childbearing potential and sexually active men must use effective contraception during the study.
Exclusion Criteria
- Have had any prior systemic treatment for this cancer.
- Have received any of the study drugs within the past 5 years.
- Have brain metastases or cancer spread to the brain lining.
- Have a known deficiency in breaking down certain drugs (DPD deficiency).
- Have uncontrolled infections, heart problems, or psychiatric conditions that would interfere with the study.
- Have a history of severe allergic reactions to similar drugs.
- Have absorption issues that affect drug intake.
- Have had certain heart or blood vessel problems within the past year.
- Have other active cancers, except for certain non-threatening types.
- Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
- Have HIV or be on antiretroviral therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| Mission Hope Medical Oncology - Arroyo Grande | 93420 | Arroyo Grande | California |
| PCR Oncology | 93420 | Arroyo Grande | California |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | 95603 | Auburn | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
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