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| 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: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors |
| Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are treated in 2 stages.
Stage I: Patients are randomized to 1 of 2 treatment arms.
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoid tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
No baseline proteinuria
Cardiovascular
None of the following within the past 6 months:
Pulmonary
Immunologic
None of the following immunologically mediated diseases:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior immunotherapy allowed
Chemotherapy
Endocrine therapy
Radiotherapy
At least 4 weeks since prior radiotherapy
Surgery
Other
Contacts and Locations| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | James Yao, MD | M.D. Anderson Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00055809 History of Changes |
| Other Study ID Numbers: | CDR0000271225, MDA-ID-02063, NCI-4772 |
| Study First Received: | March 6, 2003 |
| Last Updated: | April 26, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor |
|
Carcinoid Tumor Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Peginterferon alfa-2b Bevacizumab Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents |