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

Primary Purpose

Metastatic Gastrointestinal Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Regional Gastrointestinal Carcinoid Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEG-interferon alfa-2b
bevacizumab
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Gastrointestinal Carcinoid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (bevacizumab)

Arm II (PEG-interferon alfa-2b)

Arm Description

Patients receive bevacizumab IV on day 1.

Patients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.

Outcomes

Primary Outcome Measures

Tumor response rate (CR + PR) as measured by RECIST criteria

Secondary Outcome Measures

Progression free survival
Biochemical response rate measured after treatment
Toxicity graded according to CTC v3.0 criteria for adverse outcomes

Full Information

First Posted
March 6, 2003
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00055809
Brief Title
Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Official Title
Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Gastrointestinal Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Regional Gastrointestinal Carcinoid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (bevacizumab)
Arm Type
Experimental
Arm Description
Patients receive bevacizumab IV on day 1.
Arm Title
Arm II (PEG-interferon alfa-2b)
Arm Type
Experimental
Arm Description
Patients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.
Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2b
Other Intervention Name(s)
PEG-IFN alfa-2b, pegylated interferon alfa-2b, polyethylene glycol IFN-A2b
Intervention Description
Given SC
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Optional correlative studies
Primary Outcome Measure Information:
Title
Tumor response rate (CR + PR) as measured by RECIST criteria
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
From the time of initial treatment to the time of PD or death, assessed up to 4 years
Title
Biochemical response rate measured after treatment
Time Frame
Up to 4 years
Title
Toxicity graded according to CTC v3.0 criteria for adverse outcomes
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Yao
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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