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A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrinoma, Glucagonoma, Insulinoma, Metastatic Gastrointestinal Carcinoid Tumor, Neuroendocrine Tumor, Pancreatic Polypeptide Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma, Somatostatinoma, WDHA Syndrome

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Trial Information

A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed response rate (CR or PR) estimated by the number of successes divided by the total number of evaluable patients

Outcome Description:

Kaplan-Meier methodology will be used to estimate the final success proportion (i.e., confirmed response rate with a 95% confidence interval).

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Timothy Hobday

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00121

NCT ID:

NCT00131911

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Gastrinoma
  • Glucagonoma
  • Insulinoma
  • Metastatic Gastrointestinal Carcinoid Tumor
  • Neuroendocrine Tumor
  • Pancreatic Polypeptide Tumor
  • Recurrent Gastrointestinal Carcinoid Tumor
  • Recurrent Islet Cell Carcinoma
  • Somatostatinoma
  • WDHA Syndrome
  • Carcinoid Tumor
  • Carcinoma
  • Gastrinoma
  • Zollinger-Ellison Syndrome
  • Glucagonoma
  • Insulinoma
  • Somatostatinoma
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Carcinoma, Islet Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905