Clinical trial NCT00227617 (phase 2/phase 3, status: terminated)
Conditions: gastrointestinal carcinoid tumor, islet cell tumor, lung cancer, neoplastic syndrome, neuroendocrine tumor
ICD codes: C7A.00, C7A.010, C7A.011, C7A.012, C7A.020, C7A.021, C7A.026, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, G73.1, C7A.1, C7A.8, C7B.8, D3A.8
Drugs: 5-fluorouracil, leucovorin, oxaliplatin
SMILES: FC1=CNC(=O)NC1=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        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

          -  Primary tumors of the pancreas should not invade adjacent organs (e.g., stomach or
             duodenum)

          -  No history or evidence of brain or leptomeningeal disease (baseline CNS imaging
             required if clinical suspicion of CNS metastases)

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  More than 12 weeks

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  No history of hemoptysis or bleeding diathesis

          -  No coagulopathy unrelated to therapeutic anticoagulation

          -  No significant bleeding events within the past 6 months unless the source of the
             bleeding has been resected

        Hepatic

          -  Bilirubin < 2 mg/dL

          -  ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)

        Renal

          -  Creatinine ≤ 2 mg/dL

          -  Protein ≤ 1+ OR

          -  Protein < 1 gm on 24-hour urine collection

          -  Urine protein:creatinine ratio < 1.0

        Cardiovascular

          -  History of thromboembolic condition allowed provided patient is on therapeutic
             anticoagulation at a stable dose for ≥ 4 weeks

               -  Concurrent daily prophylactic aspirin (< 325 mg/day) allowed

          -  No uncontrolled hypertension, myocardial infarction, clinically significant peripheral
             arterial ischemia, visceral arterial ischemia or angina within the past 6 months

          -  No serious cardiac arrhythmia requiring medication

          -  No cerebrovascular event (e.g., stroke or transient ischemic attack) within the past
             12 months

          -  No history of peripheral vascular disease ≥ grade 2

          -  No history New York Heart Association class II-IV congestive heart failure

          -  Blood pressure ≤ 160/90 mm Hg

        Gastrointestinal

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No predisposing uncontrolled small bowel or colonic disorder

               -  Baseline disease-related diarrhea allowed if symptoms are stable and
                  well-characterized (i.e., # stools/day stable)

          -  No gastric or esophageal varices

          -  No gastroduodenal ulcers determined to be active by endoscopy

        Pulmonary

          -  No interstitial pneumonia or extensive and symptomatic interstitial fibrosis

          -  No lung tumor in close proximity to a major vessel, or with associated cavitation

          -  No pleural effusion or ascites that causes ≥ grade 2 dyspnea

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after completion of study treatment

          -  No significant traumatic injury within the past 28 days

          -  No currently active second malignancy other than, non-melanoma skin cancer or
             carcinoma in situ

               -  Patients are not considered to have a currently active malignancy if they have
                  completed therapy and are considered by their physician to be at ≤ 30% risk for
                  relapse

          -  No known hypersensitivity reaction attributed to study drugs or to compounds of
             similar chemical or biological composition

          -  No symptomatic peripheral neuropathy > grade 1

          -  No other severe disease or comorbidity that would preclude study participation

          -  No medically uncontrolled seizures

          -  No active infection

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other severe, concurrent disease, infection, or co-morbidity that in the judgement
             of the investigator would constitute a hazard for study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Recovered from prior cytokine therapy

          -  At least 4 weeks since prior immunotherapy

          -  No prior tyrosine kinase inhibitors or anti-vascular endothelial growth factor (VEGF)
             angiogenic inhibitors

        Chemotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior chemotherapy

          -  No prior oxaliplatin

          -  Prior chemoembolization therapy allowed provided it did not affect areas of measurable
             disease

        Endocrine therapy

          -  Prior and concurrent somatostatin analogs allowed for symptomatic control and/or
             control of hormone hypersecretion only provided treatment was initiated > 3 months
             prior to study entry

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy and recovered

               -  Prior radiotherapy must not affect areas of measurable disease

          -  No concurrent radiotherapy to only site of measurable disease

        Surgery

          -  Recovered from prior surgery

          -  Prior cryotherapy allowed provided it did not affect areas of measurable disease

          -  At least 28 days since prior major surgical procedure or open biopsy

          -  At least 7 days since minor surgical procedure, fine-needle aspirations, or core
             biopsy

          -  No prior organ allograft

          -  No concurrent major surgery

        Other

          -  At least 4 weeks since prior participation in an experimental drug study

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  No halogenated antiviral agents

          -  Concurrent antiplatelet agents allowed