Combination Chemotherapy as First-Line Therapy in Treating Patients With Locally Advanced or Meta… (NCT00416767) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors of the Duodenum or Pancreas That Cannot Be Removed By Surgery
20 participantsStarted 2004-05
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works as first-line therapy in treating patients with locally advanced or metastatic neuroendocrine tumors of the duodenum or pancreas that cannot be removed by surgery.
Who can participate
Age range
18 Years – 80 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:
* Diagnosis of neuroendocrine tumor of the duodenum/pancreas by histology or bone scan
* Functional or nonfunctional tumor
* Tumor meets ≥ 1 of the following criteria:
* Hepatic or extrahepatic metastases
* Progressive locally advanced tumor (primary or adenopathies)
* Unresectable disease
* Tumor differentiated and meets the following criteria:
* Ki 67 ≤ 15%
* Less than 10 mitoses per 10 large fields
* Measurable or evaluable disease
* Target lesions must meet 1 of the following criteria within the past 6 months:
* Increase of 20% in the longest diameter
* New metastases detected
* Minimum size of lesions must be 1 of the following:
* More than 15 mm for metastases
* More than 50 mm for primary tumor or local lymph nodes
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Creatinine ≤ 1.5 mg/dL
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.8 mg/dL
* No coronary insufficiency or symptomatic cardiac disease
* No intestinal obstruction, enteropathy, or uncontrolled chronic diarrhea
* No Gilbert's disease
* No psychological, social, familial, or geographic condition that would preclude study treatment
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after completion of study therapy
* No other condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
* No prior adjuvant radiotherapy
* At least 3 mo…
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.
Trial details
NCT IDNCT00416767
SponsorFederation Francophone de Cancerologie Digestive