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Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

Primary Purpose

Gastrointestinal Carcinoid Tumor, Islet Cell Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
octreotide acetate
vatalanib
anti-cytokine therapy
antiangiogenesis therapy
biological therapy
endocrine therapy
enzyme inhibitor therapy
growth factor antagonist therapy
hormone therapy
protein tyrosine kinase inhibitor therapy
somatostatin analogue therapy
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Carcinoid Tumor focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2005
    Last Updated
    October 6, 2015
    Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00227773
    Brief Title
    Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
    Official Title
    Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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 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.
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Carcinoid Tumor, Islet Cell Carcinoma
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    octreotide acetate
    Intervention Type
    Drug
    Intervention Name(s)
    vatalanib
    Intervention Type
    Procedure
    Intervention Name(s)
    anti-cytokine therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    antiangiogenesis therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    biological therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    endocrine therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    enzyme inhibitor therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    growth factor antagonist therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    hormone therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    protein tyrosine kinase inhibitor therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    somatostatin analogue therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyle Holen, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mary Mulcahy, MD
    Organizational Affiliation
    Robert H. Lurie Cancer Center

    12. IPD Sharing Statement

    Learn more about this trial

    Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

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