Status:
WITHDRAWN
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Carcinoid Tumor
Islet Cell Carcinoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 di...
Detailed Description
OBJECTIVES: * Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide. * Determine the response ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00227773
Last Update
October 8 2015
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