Trial Search Results

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

This randomized phase III trial is studying giving octreotide acetate together with recombinant interferon alfa-2b to see how well it works compared with giving octreotide acetate together with bevacizumab in treating patients with metastatic or locally advanced, high-risk neuroendocrine tumor. Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. 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. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)


  • Biological: Recombinant Interferon Alfa-2b
  • Drug: Octreotide Acetate
  • Biological: Bevacizumab


Phase 3


Inclusion Criteria:

   - Diagnosis of unresectable metastatic or locally advanced, low- or intermediate-grade
   neuroendocrine carcinoma, including the following subtypes:

      - Carcinoid tumor, low-grade or well differentiated neuroendocrine carcinoma

      - Atypical carcinoid tumor, intermediate-grade or moderately differentiated
      neuroendocrine carcinoma

   - High-risk disease as defined by at least one of the following:

      - Progressive disease

      - Refractory carcinoid syndrome while receiving octreotide acetate (i.e., defined
      by > 2 flushing episodes/day or > 4 bowel movements/day)

      - Atypical histology and more than 6 lesions

      - Metastatic colorectal carcinoid tumor

         - Patients with metastatic cecal or appendiceal carcinoid tumor are not
         eligible unless they fit other mentioned high-risk features

      - Metastatic gastric carcinoid tumor

   - Measurable disease

   - Patients with poorly differentiated neuroendocrine carcinoma, high-grade
   neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not

   - Osseous metastasis as only site of disease

   - Medullary thyroid carcinoma or islet cell carcinoma

   - History of primary brain tumor or metastatic cancer to the brain

   - Zubrod performance status 0-2

   - Platelet count > 100,000/mm³

   - ANC > 1,500/mm³

   - Hemoglobin > 8 g/dL

   - Serum bilirubin < 1.5 times upper limit of normal (ULN)

   - SGOT and SGPT ≤ 2.5 times ULN

   - Serum creatinine < 1.5 mg/dL

   - 24-hour urine protein < 1,000 mg if urine protein:creatinine ratio > 0.5

   - PT and PTT ≤ 1.1 times ULN

   - History of hypertension must be well controlled (i.e., blood pressure < 150/90 mm Hg)
   on a stable regimen of antihypertensive therapy

   - Not pregnant or nursing

   - Fertile patients must use effective barrier method contraception during and for 6
   months after completion of study treatment

   - History or evidence of clinically significant peripheral vascular disease (e.g.,
   non-healing peripheral ulcers or claudication)

   - Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the
   past 28 days

   - Bleeding diathesis or coagulopathy that results in spontaneous bleeding (in the
   absence of trauma) requiring red blood cell transfusion within the past 5 years

   - Serious (i.e., requiring active medical therapy with medication or medical device
   under the supervision of a physician) non-healing wound, ulcer, or bone fracture

   - Recent history (i.e., within the past 6 months) of any of the following arterial
   thromboembolic events:

      - Transient ischemic attack

      - Cerebrovascular accident

      - Unstable angina

      - Myocardial infarction

      - New York Heart Association class II or higher congestive heart failure

   - Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia

   - Pregnant or nursing

   - Any other prior malignancy within the past 5 years except for adequately treated basal
   cell or squamous cell skin cancer, or other adequately treated in situ cancer

   - Any immunologically mediated disease, including any of the following:

      - Inflammatory bowel disease (Crohn disease, ulcerative colitis)

      - Rheumatoid arthritis

      - Idiopathic thrombocytopenia purpura

      - Systemic lupus erythematosus

      - Autoimmune hemolytic anemia

      - Scleroderma

      - Severe psoriasis

   - Any serious intercurrent infections or nonmalignant medical illnesses that are
   uncontrolled or whose control may be jeopardized by the complications of this

   - Psychiatric disorders rendering patient incapable of complying with the requirements
   of the protocol

   - Recovered from all prior therapy

   - At least 28 days since and no more than 1 prior regimen of cytotoxic chemotherapy

   - At least 28 days since prior hepatic artery embolization provided there is residual
   measurable disease

      - Chemoembolization is considered as 1 prior chemotherapy regimen

   - No prior interferon, bevacizumab, or any other therapy targeting VEGF or VEGF
   receptors (e.g., SU11248, PTK/ZK, sorafenib tosylate, or pazopanib hydrochloride)

   - Prior therapy targeting c-kit, abl, PDGFR, mTOR, and somatostatin receptors allowed

   - At least 28 days since prior radiotherapy

      - Target lesions must have shown disease progression if therapy included peptide
      receptor radiotherapy

   - At least 1 week since prior minor surgery

   - At least 4 weeks since prior major surgery

   - At least 21 days since prior octreotide acetate therapy

   - Concurrent full-dose anticoagulation (warfarin or low molecular weight heparin)
   allowed provided the following criteria are met:

      - In-range INR (e.g., between 2 and 3) on a stable dose of oral anticoagulant or on
      a stable dose of low molecular weight heparin

      - No active bleeding or pathological condition that carries a high risk of bleeding
      (e.g., varices)

   - No concurrent interferon to control carcinoid syndrome for patients receiving

      - Other supportive care medication (e.g., short acting octreotide acetate) allowed

   - No other concurrent chemotherapy, immunotherapy, radiotherapy, hepatic artery
   embolization, hepatic artery chemoembolization, radiofrequency ablation, or other
   tumor ablative procedure

   - No other investigational or commercial agents

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting