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

NCT00055809 | Completed Phase 2

• 4 other identifiers: NCI-2012-02519MDA-ID-02063N01CM62202CDR0000271225
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Gastrointestinal Carcinoid Tumor; Recurrent Gastrointestinal Carcinoid Tumor; Regional Gastrointestinal Carcinoid Tumor

Outcome Measures

Primary Outcomes (1)

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

  Up to 4 years

Secondary Outcomes (3)

• Progression free survival

  From the time of initial treatment to the time of PD or death, assessed up to 4 years

• Biochemical response rate measured after treatment

  Up to 4 years

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

  Up to 4 years

Study Arms (2)

Arm I (bevacizumab)

EXPERIMENTAL

Patients receive bevacizumab IV on day 1.

Biological: bevacizumab; Other: laboratory biomarker analysis

Arm II (PEG-interferon alfa-2b)

EXPERIMENTAL

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

Biological: PEG-interferon alfa-2b; Other: laboratory biomarker analysis

Interventions

PEG-interferon alfa-2b BIOLOGICAL

Given SC

Also known as: PEG-IFN alfa-2b, pegylated interferon alfa-2b, polyethylene glycol IFN-A2b

Arm II (PEG-interferon alfa-2b)

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Arm I (bevacizumab)

laboratory biomarker analysis OTHER

Optional correlative studies

Arm I (bevacizumab); Arm II (PEG-interferon alfa-2b)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

peginterferon alfa-2b; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• James Yao

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: January 1, 2003
• Primary Completion: June 1, 2007
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)