Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

Conditions

• Colorectal Neuroendocrine Tumor G1
• Gastric Neuroendocrine Tumor G1
• Neuroendocrine Neoplasm
• Neuroendocrine Tumor
• Neuroendocrine Tumor G2

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Octreotide Acetate — DRUG
  Given IM
• Recombinant Interferon Alfa-2b — BIOLOGICAL
  Given SC

Study Details

This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.

Key Dates

First listed

Dec 6, 2007

Start date

Dec 1, 2007

Status verified

Dec 2025

Primary completion

Jan 1, 2015

Completion

Jan 31, 2027

Study Design

Enrollment

427 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (octreotide acetate and bevacizumab)
  Patients receive depot octreotide acetate IM and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (octreotide acetate and recombinant interferon alfa-2b)
  Patients receive octreotide acetate IM as in arm I on day 1 and recombinant interferon alfa-2b SC on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Central Review-based Progression-Free Survival [ Time Frame: Up to 3 years ]

Locations (494)

Find similar trials in Mobile, AL

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