Clinical trial · Interventional
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
NCT00227773CI-TRIAL-00019389withdrawnPhase 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)
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide may be an effective treatment for neuroendocrine tumors. PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Islet Cell Carcinoma | Pancreatic Neuroendocrine Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiangiogenesis therapy | Procedure | — | UNRESOLVED |
| anti-cytokine therapy | Procedure | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| endocrine therapy | Procedure | — | UNRESOLVED |
| enzyme inhibitor therapy | Procedure | — | UNRESOLVED |
| growth factor antagonist therapy | Procedure | — | UNRESOLVED |
| hormone therapy | Procedure | — | UNRESOLVED |
| octreotide acetate | Drug | — | UNRESOLVED |
| protein tyrosine kinase inhibitor therapy |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed low-grade neuroendocrine tumors * The following tumor types are excluded: * Small cell lung cancer * Medullary thyroid cancer * Paraganglioma * Pheochromocytoma * Measurable disease * Radiographic evidence of disease progression after completion of any prior systemic therapy, chemoembolization, bland embolization, or observation within the past year, defined as either of the following: * Appearance of a new lesion * At least 20% increase in the longest diameter (LD) of any previously documented lesion or an increase in the sum of the LDs of multiple lesions in the aggregate of 20% PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * Bilirubin ≤ 2.0 times upper limit of normal (ULN) * AST ≤ 3 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine ≤ 1.5 times ULN * Meets 1 of the following criteria: * Urine protein negative by dipstick * Urine protein:creatinine ratio \< 1.0 * Urine protein \< 1 g by 24-hour urine collection Gastrointestinal * Must be able to swallow tablets * No ulcerative disease * No uncontrolled nausea, vomiting, or diarrhea * No bowel obstruction * No other gastrointestinal tract disease resulting in an inability to take oral medication Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be able to receive a contrast-enhanced CT scan * No known history of allergic reaction to vatalanib or its derivatives or octreotide injections PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior chemotherapy * No more than 1 prior systemic chemotherapy regimen * Chemoembolization is not considered systemic chemotherapy * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 4 weeks since prior major surgery Other * At least 4 weeks since other prior systemic therapy * At least 4 weeks since prior local liver therapy * No prior anti-vascular endothelial growth factor agents * No concurrent grapefruit or grapefruit juice * No concurrent therapeutic warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system * Concurrent heparin allowed
References
Publications (0)
Data not yet available
No reference posted for this study.