Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

NCT00227773 | Withdrawn Phase 2

• 2 other identifiers: CDR0000446076ECOG-E6203
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Interventions

octreotide acetate DRUG

vatalanib DRUG

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 PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Carcinoma, Islet Cell; Gastrinoma; Insulinoma; Vipoma; Glucagonoma; Somatostatinoma

Interventions

Octreotide; vatalanib; Biological Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma, Islet Cell; Adenoma; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Therapeutics

Study Officials

• Kyle Holen, MD

  University of Wisconsin, Madison

  STUDY CHAIR

• Mary Mulcahy, MD

  Robert H. Lurie Cancer Center

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Last Updated: October 8, 2015

Record last verified: 2015-10