Overview
Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
This phase II trial studies how well sorafenib tosylate works in treating patients with medullary thyroid cancer that has spread to other parts of the body (metastatic), spread to the tissue surrounding the thyroid (locally advanced), or has returned after a period of improvement (recurrent). 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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)Treatments:
Niacinamide
Sorafenib
Criteria
Inclusion Criteria:- ELIGIBILITY CRITERIA SPECIFIC FOR ARM A
- Histologically confirmed medullary thyroid carcinoma under the clinical setting of
inherited tumor syndromes, such as multiple endocrine neoplasia (MEN) 2A, MEN 2B, or
familial medullary thyroid carcinoma (FMTC)
- ELIGIBILITY CRITERIA SPECIFIC FOR ARM B
- Histologically confirmed medullary thyroid carcinoma under the clinical setting of
sporadic medullary thyroid carcinoma (MTC)
- ELIGIBILITY CRITERIA COMMON FOR ARMS A AND B
- Patients must have measurable disease
- Metastatic and/or locally advanced or locally recurrent disease
- Oral or intravenous (IV) bisphosphonates therapy will be allowed for patients with
bony metastasis at the investigator's discretion; bisphosphonate usage should be
recorded if used since these agents may have anti-farnesyl transferase activity and
may have some therapeutic effect in combination with sorafenib
- Life expectancy must be >= six months
- Patients must have an Eastern Cooperative Oncology Group performance status 0-2
- Leukocytes >= 2,000/uL (10 days prior to patient enrollment)
- Absolute neutrophil count >= 1,000/uL (10 days prior to patient enrollment)
- Platelets >= 100,000/uL (10 days prior to patient enrollment)
- Total bilirubin =< within 2 x upper limit of normal (10 days prior to patient
enrollment)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< within 3 x upper limit of normal (10 days prior to patient enrollment)
- Serum creatinine within normal institutional limits OR creatinine clearance > 30
mL/min (by Cockcroft-Gault formula) (10 days prior to patient enrollment)
- The effects of sorafenib (BAY 43-9006) on the developing human fetus at the
recommended therapeutic dose are unknown; for this reason and because kinase
inhibitors are known to be teratogenic, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and for at
least 30 days after completion of therapy; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- EXCLUSION CRITERIA FOR ARM A AND B
- Patients who have had systemic anti-tumor therapy (such as chemotherapy, biologic
modifiers or antiangiogenic therapy) within 4 weeks (6 weeks if nitrosourea or
mitomycin chemotherapy) prior to study entry
- Patients who have had external beam radiation therapy within 1 week or if the adverse
events associated with radiation are not resolved to grade 1 or less prior to study
entry
- Prior therapy with sorafenib (BAY 43-9006), ZD 6474 or AMG-706
- Patients currently receiving any other tumor-specific therapy for thyroid cancer or
investigational therapy; patients receiving adjuvant hormonal therapy for a second
primary (such as breast cancer or prostate cancer) are allowed to participate as far
as there are no known drug interactions
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sorafenib (BAY 43-9006)
- Patients unable to swallow sorafenib tablets (e.g. any condition that impairs
patient's ability to swallow pills)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, uncontrolled hypertension, or psychiatric illness/social situations that
would limit compliance with study requirements
- Patients with any evidence of a bleeding diathesis
- Patients actively receiving anticoagulation with therapeutic intent; prophylactic
anticoagulation (i.e. low dose warfarin) or venous or arterial access devices is
allowed provided that the prothrombin time (PT), international normalized ratio (INR)
or partial thromboplastin time (PTT) are normal
- Pregnant women or women who are breast-feeding are excluded from this study because
sorafenib (BAY 43-9006) is an investigational agent and teratogenicity has not been
evaluated yet; because there is an unknown but potential risk for adverse events in
nursing infants secondary to treatment of the mother with sorafenib (BAY 43-9006),
breastfeeding should be discontinued if the mother is treated with sorafenib (BAY
43-9006)
- Human immunodeficiency virus (HIV)-positive patients receiving combination
anti-retroviral therapy because of possible pharmacokinetic interactions with
sorafenib (BAY 43-9006); patients with immune deficiency are at increased risk of
lethal infections when treated with marrow-suppressive therapy
- Patients taking the cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin,
carbamazepine, or phenobarbital), rifampin or St. John's wort due to potential drug
interactions with sorafenib