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Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131911
First Posted: August 19, 2005
Last Update Posted: November 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Gastrinoma Glucagonoma Insulinoma Metastatic Gastrointestinal Carcinoid Tumor Neuroendocrine Tumor Pancreatic Polypeptide Tumor Recurrent Gastrointestinal Carcinoid Tumor Recurrent Islet Cell Carcinoma Somatostatinoma WDHA Syndrome Drug: sorafenib tosylate Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed Response Rate [ Time Frame: Duration of Treatment (Up to 2 years) ]

    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.



Secondary Outcome Measures:
  • Toxicity [ Time Frame: Up to 2 years ]
    For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of participants reporting a grade 3 or higher toxicity are reported.

  • Overall Survival [ Time Frame: From registration to death (up to 2 years) ]
    Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.

  • Progression Free Survival [ Time Frame: Time from registration to progression or death (up to 2 years) ]
    Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST) as a 20% increase in the su of longest diameter of target lesions. Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Participants who were progression free were censored at the date of their most recent disease assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.

  • Duration of Response [ Time Frame: Time from response to progression (up to 2 years) ]
    Duration of response (DOR) was defined as the time from attaining a response (PR or CR) to the date of progression. Participants without progression were censored at the date of their most recent disease assessment. The median DOR was estimated using simple summary statistics.


Enrollment: 93
Study Start Date: June 2005
Study Completion Date: April 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A (patients with carcinoid tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
Drug: sorafenib tosylate
400 mg given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Experimental: Group B (islet cell and other neuroendocrine tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
Drug: sorafenib tosylate
400 mg given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in patients with advanced neuroendocrine tumors.

SECONDARY OBJECTIVES:

I. Adverse event rate(s). II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival.

OUTLINE: This is a multicenter study. Patients are grouped into 2 separate analysis Groups according to tumor type (Group A: Carcinoid; Group B: Islet cell/other well-differentiated tumor). Each Group was independently evaluated for all study endpoints.

Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131911


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Timothy Hobday Mayo Clinic
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00131911     History of Changes
Other Study ID Numbers: NCI-2009-00121
MC044H
7046
CDR0000437792
N01CM62205 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2005
First Posted: August 19, 2005
Results First Submitted: June 19, 2014
Results First Posted: November 17, 2014
Last Update Posted: November 17, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Gastrointestinal Neoplasms
Insulinoma
Carcinoma, Islet Cell
Gastrinoma
Somatostatinoma
Glucagonoma
Vipoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Adenoma, Islet Cell
Adenoma
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Neuroendocrine
Sorafenib