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Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055809
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This randomized phase II trial is to see if combining bevacizumab with PEG-interferon alfa-2b works in treating patients who have metastatic or unresectable carcinoid tumors. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. Combining bevacizumab with PEG-interferon alfa-2b may kill more cancer cells

Condition or disease Intervention/treatment Phase
Metastatic Gastrointestinal Carcinoid Tumor Recurrent Gastrointestinal Carcinoid Tumor Regional Gastrointestinal Carcinoid Tumor Biological: PEG-interferon alfa-2b Biological: bevacizumab Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. Determine the progression-free survival rate in patients with metastatic or unresectable carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b.

II. Determine the tumor response rate (complete and partial) in patients treated with this regimen.

III. Determine the biochemical response rate of patients treated with this regimen.

IV. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are treated in 2 stages.

Stage I: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive bevacizumab IV on day 1.

Arm II: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1, 8, and 15.

In both arms, courses repeat every 3 weeks. Patients with progressive disease at 9 weeks proceed to stage II. All other patients proceed to stage II after 18 weeks on stage I.

Stage II: Patients receive bevacizumab IV on day 1 and PEG-interferon alfa-2b SC once weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) and remain in CR for 2 additional courses come off study. Patients are followed for survival.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors
Study Start Date : January 2003
Actual Primary Completion Date : June 2007

Arm Intervention/treatment
Experimental: Arm I (bevacizumab)
Patients receive bevacizumab IV on day 1.
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

Other: laboratory biomarker analysis
Optional correlative studies

Experimental: Arm II (PEG-interferon alfa-2b)
Patients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.
Biological: PEG-interferon alfa-2b
Given SC
Other Names:
  • PEG-IFN alfa-2b
  • pegylated interferon alfa-2b
  • polyethylene glycol IFN-A2b

Other: laboratory biomarker analysis
Optional correlative studies

Primary Outcome Measures :
  1. Tumor response rate (CR + PR) as measured by RECIST criteria [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: From the time of initial treatment to the time of PD or death, assessed up to 4 years ]
  2. Biochemical response rate measured after treatment [ Time Frame: Up to 4 years ]
  3. Toxicity graded according to CTC v3.0 criteria for adverse outcomes [ Time Frame: Up to 4 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed carcinoid tumor

    • Metastatic or unresectable local-regional disease
  • Measurable disease
  • No osseous metastasis as the only site of disease
  • No history or clinical evidence of CNS disease (e.g., primary brain tumor or any brain metastasis)
  • Performance status - Zubrod 0-2
  • Performance status - Karnofsky 70-100%
  • At least 12 weeks
  • See Immunologic
  • Absolute granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 8 g/dL
  • No bleeding diathesis or coagulopathy
  • No hemoglobinopathies (e.g., thalassemia) or any other cause of hemolytic anemia
  • Bilirubin < 1.5 mg/dL
  • INR < 1.5 (if receiving warfarin)
  • No evidence of decompensated liver disease (e.g., ascites, bleeding varices, or spontaneous encephalopathy)
  • Creatinine < 1.5 mg/dL
  • No baseline proteinuria

    • Patients with proteinuria (≥ 2+ or ≥ 100 mg/dL on urinalysis) are allowed provided 24-hour urinary protein is < 500 mg
  • No New York Heart Association grade II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No clinically significant peripheral vascular disease
  • No history of stroke
  • None of the following within the past 6 months:

    • Uncontrolled hypertension
    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina
    • Myocardial infarction
  • No chronic pulmonary disease (e.g., chronic obstructive pulmonary disease)
  • No documented pulmonary hypertension
  • None of the following immunologically mediated diseases:

    • Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
    • Rheumatoid arthritis
    • Idiopathic thrombocytopenia purpura
    • Systemic lupus erythematosus
    • Autoimmune hemolytic anemia
    • Scleroderma
    • Severe psoriasis
  • No serious concurrent infections
  • No active infection requiring parental antibiotics on day 0
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No known hypersensitivity to interferon alfa or to any excipient or vehicle included in its formulation or delivery system
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant traumatic injury within the past 4 weeks
  • No preexisting thyroid abnormality for which thyroid function can not be normalized by medication
  • No concurrent nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of this study therapy
  • No uncontrolled psychiatric disorder
  • No psychiatric disorders that would preclude study compliance
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No serious nonhealing wound ulcer or bone fracture
  • No seizures not controlled with standard medical therapy
  • Prior immunotherapy allowed

    • No prior interferon
  • No concurrent immunotherapy
  • At least 4 weeks since prior chemotherapy, including radiosensitizers
  • No more than 1 prior chemotherapy regimen, including radiosensitizers
  • No concurrent chemotherapy
  • At least 4 weeks since prior radiotherapy

    • Prior radiotherapy must not have contained the single evaluable lesion of this study in a radiation field
  • No concurrent radiotherapy
  • At least 4 weeks since prior major surgery or open biopsy (1 week for minor surgery) and recovered
  • No concurrent or recent full-dose anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters)
  • No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055809

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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: James Yao M.D. Anderson Cancer Center

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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00055809    
Other Study ID Numbers: NCI-2012-02519
N01CM62202 ( U.S. NIH Grant/Contract )
CDR0000271225 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents, Immunological
Antibodies, Monoclonal
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs