Clinical trial · Interventional
Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
NCT00137774CI-TRIAL-00009949completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma * Measurable disease \> 1cm by spiral computed tomography (CT) or \> 2cm by other radiographic technique * ECOG performance status of 0-2 * Life expectancy of \> 12 weeks * Prior treatment with chemotherapy is allowed * Total bilirubin \< 2.0mg/dl * AST \< 5x upper limit of normal (ULN) * Serum creatinine \< 2.0mg/dl * Absolute neutrophil count \> 1,000/mm3 * Platelets \> 100,000/mm3 * International Normalized Ratio (INR) \< 1.5 Exclusion Criteria: * Prior treatment with temozolomide, decarbazine or bevacizumab * Clinically apparent central nervous system metastases or carcinomatous meningitis * Clinically significant cardiovascular disease * Major surgery, open biopsy, or significant traumatic injury within 28 days * Pregnant or breast-feeding women * Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medication * Serious, nonhealing wound, ulcer or bone fracture * Evidence of bleeding diathesis or coagulopathy * History of other disease or metabolic dysfunction
References
Publications (1)
- RESULTChan JA, Stuart K, Earle CC, Clark JW, Bhargava P, Miksad R, Blaszkowsky L, Enzinger PC, Meyerhardt JA, Zheng H, Fuchs CS, Kulke MH. Prospective study of bevacizumab plus temozolomide in patients with advanced neuroendocrine tumors. J Clin Oncol. 2012 Aug 20;30(24):2963-8. doi: 10.1200/JCO.2011.40.3147. Epub 2012 Jul 9. PMID 22778320