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 range18 Years – 80 Years
SexALL
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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…
Trial details
NCT IDNCT00416767
SponsorFederation Francophone de Cancerologie Digestive