Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

NCT00131911 | Completed Phase 2 Results

• 5 other identifiers: NCI-2009-00121MC044H7046CDR0000437792N01CM62205
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Conditions

Gastrinoma; Glucagonoma; Insulinoma; Metastatic Gastrointestinal Carcinoid Tumor; Neuroendocrine Tumor; Pancreatic Polypeptide Tumor; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma; Somatostatinoma; WDHA Syndrome

Outcome Measures

Primary Outcomes (1)

• Confirmed Response Rate

  Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients.\> \> Complete Response (CR) is defined as the disappearance of all target lesions.\> Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions;\> \> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method.

  Duration of Treatment (Up to 2 years)

Secondary Outcomes (4)

• Toxicity

  Up to 2 years

• Overall Survival

  From registration to death (up to 2 years)

• Progression Free Survival

  Time from registration to progression or death (up to 2 years)

• Duration of Response

  Time from response to progression (up to 2 years)

Study Arms (2)

Group A (patients with carcinoid tumors)

EXPERIMENTAL

Patients receive 400 mg oral sorafenib twice daily on days 1-28.

Drug: sorafenib tosylate

Group B (islet cell and other neuroendocrine tumors)

EXPERIMENTAL

Patients receive 400 mg oral sorafenib twice daily on days 1-28.

Drug: sorafenib tosylate

Interventions

sorafenib tosylate DRUG

400 mg given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Group A (patients with carcinoid tumors); Group B (islet cell and other neuroendocrine tumors)

Eligibility Criteria

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

Criteria: * Histologically confirmed neuroendocrine tumor: * Carcinoid tumor OR islet cell carcinoma/other well-differentiated tumor * No anaplastic or high-grade histology * Metastatic disease * Measurable disease * No thyroid carcinoma of any histology, thymoma, or pheochromocytoma/paraganglioma * No known brain metastases * Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-2 * Life expectancy: * At least 24 weeks * Hematopoietic: * Absolute neutrophil count \>= 1,500/mm3 * Platelet count \>= 100,000/mm3 * No bleeding diathesis * Hepatic: * Bilirubin =\< 2 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) =\< 3 times ULN (5 times ULN if liver metastases are present) * International normalized ratio (INR) normal * PTT normal * Renal: * Creatinine =\< 1.5 times ULN * Cardiovascular: No poorly controlled hypertension; No symptoms of congestive heart failure; No unstable angina pectoris; No cardiac arrhythmia * Gastrointestinal: * Able to swallow capsules intact * No gastrointestinal tract disease resulting in an inability to take oral medication (e.g., dysphagia) * No requirement for IV alimentation * No active peptic ulcer disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other invasive malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other uncontrolled illness * At least 4 weeks since prior interferon * No more than 1 prior systemic chemotherapy regimen: Chemoembolization is not considered systemic chemotherapy * At least 4 weeks since prior chemoembolization * At least 3 weeks since prior radiotherapy * No prior procedures adversely affecting intestinal absorption * At least 4 weeks since prior hepatic artery embolization * No other prior systemic therapy * No other concurrent investigational treatment * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin) * No concurrent rifampin * No concurrent Hypericum perforatum (St. John's wort) * Prior or concurrent octreotide for symptomatic treatment allowed * No concurrent therapeutic anticoagulation: Concurrent prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices allowed provided requirements for INR or PTT are met * At least 4 weeks since prior major surgery * Recovered from all prior therapy

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

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

Interventions

Sorafenib

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; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Neuroendocrine

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Timothy J. Hobday M.D.
• Organization: Mayo Clinic Cancer Center

Hobday.timothy@mayo.edu

Study Officials

• Timothy Hobday

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2005
• First Posted: August 19, 2005
• Study Start: June 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2013
• Last Updated: November 17, 2014
• Results First Posted: November 17, 2014

Record last verified: 2014-06

Locations

US (1)