AzTrials
AzTrials

Metastatic Gastrointestinal Carcinoid TumorPhase 2NCT00055809

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

A Phase 2 study testing PEG-interferon alfa-2b, bevacizumab and laboratory biomarker analysis in people with Metastatic Gastrointestinal Carcinoid Tumor and Recurrent Gastrointestinal Carcinoid Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PEG-interferon alfa-2b, bevacizumab and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Jan 2003to Jun 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 67Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors

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

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
PEG-interferon alfa-2b, bevacizumab, laboratory biomarker analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-interferon alfa-2bBiological

    Also called PEG-IFN alfa-2b, pegylated interferon alfa-2b, polyethylene glycol IFN-A2b

    Given SC

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • laboratory biomarker analysisOther

    Optional correlative studies

Study groups in NCT00055809
Study groupRoleWhat they receive
Arm I (bevacizumab)ExperimentalPatients receive bevacizumab IV on day 1.
Receives: Biological: bevacizumab; Other: laboratory biomarker analysis
Arm II (PEG-interferon alfa-2b)ExperimentalPatients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.
Receives: Biological: PEG-interferon alfa-2b; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 4 years

Secondary outcomes (3)

  1. Progression free survival

    Measured: 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

    Measured: Up to 4 years

  3. Toxicity graded according to CTC v3.0 criteria for adverse outcomes

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055809
Sponsor's protocol ID
NCI-2012-02519
Other IDs
MDA-ID-02063, N01CM62202, CDR0000271225
Status last verified
Jan 2013
First submitted
6 Mar 2003
Last updated
23 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-interferon alfa-2b, bevacizumab and laboratory biomarker analysis in people with Metastatic Gastrointestinal Carcinoid Tumor and Recurrent Gastrointestinal Carcinoid Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 67 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response rate (CR + PR) as measured by RECIST criteria (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in