A PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN PATIENTS METASTATIC OR UNRESECTABLE LOCALLY-ADVANCED THYROID CANCER REFRACTORY TO, OR NOT SUITABLE CANDIDATES FOR 131I TREATMENT
- Conditions
- Treatment of patients with 131I-refractory metastatic or unresectable locally-advanced papillary, follicular, or Hurthle-cell thyroid cancer who are also refractory to, or intolerant of, or have clinical contraindication to, doxorubicin treatment.MedDRA version: 8.1Level: LLTClassification code 10055107Term: Thyroid cancer metastatic
- Registration Number
- EUCTR2006-002576-18-CZ
- Lead Sponsor
- Pfizer Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1. Histologically documented, or 131I-inappropriate metastatic or unresectable locallyadvanced thyroid cancer including papillary, follicular, Hurthle cell, medullary, or
anaplastic histologies plus any one of the following: o Failure of 131I to control the disease (documented with radiographic evidence of disease progression defined by RECIST within 12 months prior to enrollment) or 131I is not an appropriate therapy (anaplastic or medullary histology), or lack of iodine uptake by one or more tumors as documented by radioiodine scan. OR o 131I-refractory and failure of doxorubicin (either as a single agent or in combination with other agents) to control the disease, documented with radiographic evidence of disease progression as defined by RECIST criteria and documented with 2 sets of CT/MRI scans (or 2 sets of chest x-rays, bone scans, or x-rays of bone lesion) during doxorubicin therapy or within 12 months after the last dose of doxorubicin
2. If a patient has only locally-advanced cancer without distant metastasis, in addition to satisfying the above inclusion criteria, the disease must also be unresectable (eg, tumor involving vital structure, history of previous surgery in the same area, or concurrent severe medical condition that prevents surgery) AND must be refractory to external beam radiotherapy.
3. At least 1 measurable target lesion, as defined by RECIST. If the only measurable
target lesion is located in an externally irradiated field, this lesion may be used as
measurable disease only if the lesion diameter has grown by =20 % since completion of the prior external irradiation or if the lesion is a new lesion, assuming all other criteria are met.
4. Adequate hepatic, and renal function documented within 14 days prior to treatment as documented by:
- AST and ALT =2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT =5.0 x ULN
- total bilirubin =1.5 x ULN
- serum creatinine =1.5 x ULN or calculated creatinine clearance =60 mL/min
- urinary protein <1+ by urine dipstick. If dipstick is =1+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours
5. Age =18 years.
6. ECOG performance status of 0 or 1
7. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be =140, and the baseline diastolic blood pressure readings must be =90. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
8. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of MDASI.
10. Written and voluntary informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Thyroid lymphoma
2. Bleeding from lung (as evidenced by hemoptysis) >½ tsp of bright red blood per day within past 1 week
3. Gastrointestinal abnormalities including:
- inability to take oral medication
- requirement for intravenous alimentation
- prior surgical procedures affecting absorption including gastric resection
- treatment for active peptic ulcer disease in the past 6 months
- active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
- malabsorption syndromes.
4. Previous treatment with anti-angiogenesis agents including thalidomide, Sutent (SU-011248), AMG 706, sorafenib, and bevacizumab.
5. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine).
6. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John’s wort).
7. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
8. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
9. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism.
10. History of a malignancy (other than thyroid cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years.
11. Major surgical procedure within 4 weeks of treatment.
12. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
13. Patients (male and female) having procreative potential who are not using adequate contraception or practicing abstinence.
14. Women who are pregnant or breast-feeding
15. Requirement of anticoagulant therapy except for low-dose anticoagulants for maintenance of patency of central venous access or prevention of deep vein thrombosis
16. History of hemorrhagic or thrombotic cerebro-vascular event in the past 12 months (DVT)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method