Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Carcinoid Tumor Islet Cell Carcinoma |
Drug: octreotide acetate Drug: vatalanib Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological therapy Procedure: endocrine therapy Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy Procedure: hormone therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: somatostatin analogue therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors |
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 rate in patients treated with this regimen.
- Determine the effect of this regimen on tumor markers (e.g., chromogranin A, 5-HIAA, and gastrin) in these patients.
- Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral vatalanib once daily on days 1- 28 and octreotide* intramuscularly or IV on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients on a stable dose (i.e., no changes in dosage within the past 3 months) of octreotide before study entry remain on their current dose and schedule during study participation; patients who experience hypersensitivity and/or toxicity to octreotide may receive vatalanib alone.
After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00227773 History of Changes |
| Other Study ID Numbers: | CDR0000446076, ECOG-E6203 |
| Study First Received: | September 26, 2005 |
| Last Updated: | October 24, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
localized gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor recurrent islet cell carcinoma gastrinoma |
insulinoma WDHA syndrome glucagonoma pancreatic polypeptide tumor somatostatinoma |
Additional relevant MeSH terms:
|
Carcinoid Tumor Carcinoma Neuroendocrine Tumors Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Carcinoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Pancreatic Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Enzyme Inhibitors Vatalanib Mitogens Hormones Somatostatin Octreotide Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Mitosis Modulators |
ClinicalTrials.gov processed this record on May 16, 2013