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Status:

TERMINATED

Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

Genentech, Inc.

Sanofi

Conditions:

Gastrointestinal Carcinoid Tumor

Islet Cell Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief 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...

Detailed Description

OBJECTIVES: Primary * Determine the safety of fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX) with bevacizumab in patients with advanced neuroendocrine tumors. * Determine the best overal...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 8 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2016

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT00227617

    Start Date

    June 8 2005

    End Date

    February 1 2016

    Last Update

    May 22 2023

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Univeristy of California, San Francisco

    San Francisco, California, United States, 94115

    2

    Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, United States, 94589