Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors (NCT00227617) | Clinical Trial Compass
TerminatedPhase 2/3
Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors
Stopped: Low accrual
United States36 participantsStarted 2005-06-08
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of neuroendocrine tumors by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with advanced neuroendocrine tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed neuroendocrine tumor (NET)
* Carcinoid at any site, with or without carcinoid syndrome
* Pancreatic islet cell tumor
* Prior streptozocin-based therapy not required
* Poorly differentiated NET of any primary site (this arm closed to accrual May 2009)
* Progression with prior treatment with cisplatin-, or carboplatin-based chemotherapy required (unless contraindicated)
* The following tumors are not allowed:
* Endocrine organ carcinoma
* Adrenal gland malignancies
* Thyroid carcinoma of any histology
* Pheochromocytoma/paraganglioma
* Advanced disease
* Disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
* Radiologically or clinically confirmed progressive disease
* At least 25% increase in radiologically or clinically measurable disease
* At least 20% increase in the longest diameter (LD) of any previously documented lesion
* Increase in the sum of the LD of multiple lesions in aggregate of 20%, OR appearance of new lesions OR deterioration in clinical status
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional radiographic techniques OR ≥ 10 mm by spiral CT scan
* Ultrasound or positron-emission tomography alone not sufficient
* Bone lesions, ascites, peritoneal carcinomatosis, pleural or pericardial effusion, and irradiated lesions are not considered measurable disease
* Prima…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment
Timeframe: From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years
2
Best Objective Response
Timeframe: From Baseline until disease progression, up to 8 years