Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine
Completed · Phase 2
Conditions studied: Recurrent Thyroid Gland Carcinoma, Stage I Thyroid Gland Papillary Carcinoma, Stage II Thyroid Gland Papillary Carcinoma, Stage III Thyroid Gland Papillary Carcinoma, Stage IV Thyroid Gland Papillary Carcinoma
In brief
This phase II trial is studying how well selumetinib works in treating patients with papillary thyroid cancer that did not respond to radioactive iodine. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Key facts
- Study ID
- NCT00559949
- Run by
- National Cancer Institute (NCI)
- People needed
- 39
- Starts
- 2007-12-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2017-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed papillary thyroid cancer or papillary thyroid cancer with follicular elements
- No longer amenable to radioactive iodine therapy or curative surgical resection
- Tumor is no longer iodine avid
- Tumor did not respond to the most recent radioactive iodine treatment
- Patient is ineligible for further radioactive iodine therapy due to medical contraindications (e.g., lung toxicity)
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- Evidence of disease progression (objective growth of existing tumors)
- New or enlarging measurable lesions within the past 12 months
- If the most recent imaging study is older than 12 months, patients will still be eligible if objectively measurable disease progression is associated with clinical symptoms
- Archival tumor tissue available for mutational analysis
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- WBC ≥ 3,000/µL
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Total bilirubin normal
- AST and ALT < 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to, during, and for 4 weeks after completion of study treatment
- Able to understand and willing to sign a written informed consent document
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib (AZD6244) or its excipient Captisol®
- QTc interval > 450 msec or other factors that increase the risk of QT prolongation
Where it is running
- Moffitt Cancer Center — Tampa, Florida, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
- University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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