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Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
This study has been completed.
First Received: March 6, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00055809
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Biological: PEG-interferon alfa-2b
Biological: bevacizumab
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate as measured by RECIST criteria after 18 weeks of treatment, and then after completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival measured after treatment [ Designated as safety issue: No ]
  • Biochemical response rate measured after treatment [ Designated as safety issue: No ]
  • Safety as measured by CTC v3.0 criteria for adverse outcomes throughout the trial [ Designated as safety issue: Yes ]

Study Start Date: January 2003
Detailed Description:

OBJECTIVES:

  • Determine the progression-free survival rate in patients with metastatic or unresectable carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b.
  • Determine the tumor response rate (complete and partial) in patients treated with this regimen.
  • Determine the biochemical response rate of patients treated with this regimen.
  • 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.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2 OR
  • Karnofsky 70-100%

Life expectancy

  • At least 12 weeks

Hematopoietic

  • 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

Hepatic

  • 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)

Renal

  • 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

Cardiovascular

  • 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

Pulmonary

  • No chronic pulmonary disease (e.g., chronic obstructive pulmonary disease)
  • No documented pulmonary hypertension

Immunologic

  • 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

Other

  • 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 CONCURRENT THERAPY:

Biologic therapy

  • Prior immunotherapy allowed

    • No prior interferon
  • No concurrent immunotherapy

Chemotherapy

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

Endocrine therapy

  • Not specified

Radiotherapy

  • 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

Surgery

  • At least 4 weeks since prior major surgery or open biopsy (1 week for minor surgery) and recovered

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055809

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: James Yao, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000271225, MDA-ID-02063, NCI-4772
Study First Received: March 6, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00055809     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent gastrointestinal carcinoid tumor
metastatic gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Bevacizumab
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon-alpha
Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Interferons
Malignant Carcinoid Syndrome
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases
Peginterferon alfa-2b
Gastrointestinal Neoplasms
Carcinoid Tumor

ClinicalTrials.gov processed this record on November 30, 2009