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New treatment option for Metastatic Malignant Neoplasm in the Liver
Official title Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
ClinicalTrials.gov ID: NCT05040360
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic malignant neoplasm in the liver.
Also referred to as Ro 09-1978/000, Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days...
- Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
- Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to...
- Participants with localized resected pNETS must have a Zaidi score of \>= 3 derived by the following factors and points:
- 1 point; symptomatic tumor defined as one of the following:
You likely can't join if
- Participants must not have unresected or unablated metastatic disease
- Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
- Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to...
- Participants must not have received somatostatin analogs after surgery
- Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
- Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or...
See the full eligibility criteria
- Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 120 days prior to registration. Participants must have a scan within 90 days...
- Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
- Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \>= 3% and =\< 55%. Treating...
- Participants with localized resected pNETS must have a Zaidi score of \>= 3 derived by the following factors and points:
- 1 point; symptomatic tumor defined as one of the following:
- Gastrointestinal bleed
- Jaundice
- Gastrointestinal obstruction
- Pain from primary tumor prior to surgical resection
- Pancreatitis
- 2 points; primary pancreas tumor size \> 2 cm
- 1 point; Ki-67 3% to 20%
- 1 point; lymph node positivity = 1
- 6 points; Ki-67 21% to 55%
- Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
- Participants must have recovered from effects of surgery as determined by the treating investigator
- Participants must be \>= 18 years old
- Participants must have Zubrod performance status of 0-2
- Participants must have a complete medical history and physical exam within 28 days prior to registration
- Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration)
- Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
- Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
- Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior...
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration)
- Serum creatinine =\< 1.5 x institutional ULN (within 28 days prior to registration)
- Calculated creatinine clearance \>= 50 ml/min (within 28 days prior to registration)
- Participants must be able to swallow pills
- Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
- No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II...
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- Participants must not have unresected or unablated metastatic disease
- Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
- Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
- Participants must not have received somatostatin analogs after surgery
- Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
- Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
- Participants must not have known absorption issues that would limit the ability to absorb study agents
- Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration
- Participants must not have active or uncontrolled infection
- Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
- Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of...
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Gilbert, Arizona, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Arroyo Grande, California, United States
- Beverly Hills, California, United States
- Buena Park, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
- Emeryville, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Martinez, California, United States
+ 285 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Gilbert, Arizona, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States and 299 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.