Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00131911
First received: August 16, 2005
Last updated: April 9, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 (CR or PR) estimated by the number of successes divided by the total number of evaluable patients [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier methodology will be used to estimate the final success proportion (i.e., confirmed response rate with a 95% confidence interval).
Secondary Outcome Measures:
- Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
- Biochemical levels and response defined as reduction in elevated hormone level by at least 50% or normalization of an elevated value [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Changes in hormone levels will be assessed via summary statistics, graphical techniques, and nonparametric methods, as well as correlated with radiographic response.
- Survival time [ Time Frame: From registration to death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: From randomization to documentation of disease progression, assessed up to 2 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Duration of response [ Time Frame: The date from which the patients objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 2 years ] [ Designated as safety issue: No ]Descriptively summarized and graphically evaluated.
- Time to treatment failure [ Time Frame: From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2005 |
| Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28.
|
Drug: sorafenib tosylate
Given orally
Other Names:
|
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 stratified according to tumor type (carcinoid vs islet cell/other well-differentiated tumor).
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- 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)
- AST =< 3 times ULN (5 times ULN if liver metastases are present)
- 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 More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00131911 History of Changes |
| Other Study ID Numbers: | NCI-2009-00121, MC044H, 7046, CDR0000437792, N01CM62205 |
| Study First Received: | August 16, 2005 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoid Tumor Carcinoma Gastrinoma Zollinger-Ellison Syndrome Glucagonoma Insulinoma Somatostatinoma 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 Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer |
ClinicalTrials.gov processed this record on May 16, 2013