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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.
 
ClinicalTrials.gov Identifier: NCT00055809
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 6, 2003
First Posted Date  ICMJE March 7, 2003
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE January 2003
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Tumor response rate (CR + PR) as measured by RECIST criteria [ Time Frame: Up to 4 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • Progression free survival [ Time Frame: From the time of initial treatment to the time of PD or death, assessed up to 4 years ]
  • Biochemical response rate measured after treatment [ Time Frame: Up to 4 years ]
  • Toxicity graded according to CTC v3.0 criteria for adverse outcomes [ Time Frame: Up to 4 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Official Title  ICMJE Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors
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
Detailed Description

OBJECTIVES:

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Gastrointestinal Carcinoid Tumor
  • Recurrent Gastrointestinal Carcinoid Tumor
  • Regional Gastrointestinal Carcinoid Tumor
Intervention  ICMJE
  • Biological: PEG-interferon alfa-2b
    Given SC
    Other Names:
    • PEG-IFN alfa-2b
    • pegylated interferon alfa-2b
    • polyethylene glycol IFN-A2b
  • 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
Study Arms  ICMJE
  • Experimental: Arm I (bevacizumab)
    Patients receive bevacizumab IV on day 1.
    Interventions:
    • Biological: bevacizumab
    • Other: laboratory biomarker analysis
  • Experimental: Arm II (PEG-interferon alfa-2b)
    Patients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.
    Interventions:
    • Biological: PEG-interferon alfa-2b
    • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
44
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00055809
Other Study ID Numbers  ICMJE NCI-2012-02519
MDA-ID-02063
N01CM62202 ( U.S. NIH Grant/Contract )
CDR0000271225 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Yao M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP