Clinical trial · Interventional
Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | CURATED_BROADER | 0.78 |
| Recurrent Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | CURATED_BROADER | 0.78 |
| Regional Gastrointestinal Carcinoid Tumor | Regional Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (bevacizumab)
- description
- Patients receive bevacizumab IV on day 1.
- interventionNames
- Biological: bevacizumab
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (PEG-interferon alfa-2b)
- description
- Patients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.
- interventionNames
- Biological: PEG-interferon alfa-2b
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Tumor response rate (CR + PR) as measured by RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available