Treatment for Patients With Metastatic Thyroid Cancer

NCT00176748

Last updated date
Study Location
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thyroid Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

To be eligible for the study, subjects must satisfy all the following criteria:

1. Histologically documented thyroid cancer with metastases.

2. Failure of 131I to control the disease or 131I is not an appropriate therapy (eg, due to lack of iodine uptake by the tumor).

3. No expectation of further effects of prior anticancer therapy.

4. At least 1 target lesion, as defined by RECIST (Appendix C), that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease assuming all other criteria are met. All target lesions must have a unidimensional diameter of at least 2 cm. (1 cm is acceptable for spiral CT scans if the reconstruction algorithm is 0.5 cm). Baseline measurements/evaluations must be completed within 4 weeks prior to treatment.

5. Adequate bone marrow, hepatic, and renal function documented within 14 days prior to treatment as documented by:

- Absolute neutrophil count (ANC, calculated as the absolute number of neutrophils and bands) ≥1.5 x 109 cells/L

- Platelets ≥100 x 109 cells /L

- 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 <2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours

6. Age ≥18 years.

7. ECOG performance status of 0 or 1 (see Appendix D)

8. 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.

9. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment.

10. Written and voluntary informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Subjects with one or more of the following criteria are ineligible for this study:


1. Central lung lesions involving major blood vessels (arteries or veins). (Central
lesions that maintain the structural integrity of vessels have the potential to bleed
if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any
case where there is any question as to whether blood vessels are involved.)


2. History of hemoptysis


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, or inhibitors
of epidermoid growth factor (EGF), platelet derived growth factor (PDGF), or
fibroblast growth factors (FGF) receptors.


5. Current use or anticipated inability to avoid use of 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 inability to avoid use of 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.


8. A serious uncontrolled medical disorder or active infection that would impair their
ability to receive study treatment.


9. 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


10. Major surgical procedure or any radiation therapy within 4 weeks of treatment.


11. Dementia or significantly altered mental status that would prohibit the understanding
or rendering of informed consent and compliance with the requirements of this
protocol.


12. Patients (male and female) having procreative potential who are not using adequate
contraception or practicing abstinence


13. Women who are pregnant or breast-feeding.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Treatment for Patients With Metastatic Thyroid Cancer
Official Title  ICMJE Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131I Treatment
Brief Summary This study is being done to find out the good and bad effects of an investigational drug that is not approved for sale, called AG-013736. Tumors need blood vessels in order to continue to grow, and AG-013736 is thought to work by playing a role in preventing new blood vessels from growing. We want to see if AG-013736 has any effect on your disease by making your tumor smaller and if so, for how long. We also want to test the safety [the effect on your body] of AG-013736 and to measure the amount of AG-013736 that gets into your blood. AG-013736 has been given to over 140 patients with cancer on other studies.
Detailed Description

The American Cancer Society estimates that there will be about 23,600 new cases of thyroid cancer (5,960 in men and 17,640 in women) annually in the United States, and about 1,460 people (620 men and 840 women) will die from this disease.1 It is the most common malignancy of the endocrine system. Depending upon type and stage, thyroid cancer may be treated with surgery, radioactive iodine (131I), hormone treatment, external radiation, or chemotherapy.

The systemic therapy of metastatic disease remains palliative until new agents are found that might afford a better prognosis. Thyroid tumors are often vascular, and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients. An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the VEGF receptor tyrosine kinase (VEGFR TK) signaling pathway. The VEGFR TK inhibitor SU011248 has produced 4 objective responses in 15 patients receiving the drug on Phase 1 studies.2 AG-013736 is another VEGFR TK inhibitor. Besides having potential anti-angiogenesis properties through VEGFR TK inhibition, it also has additional potential antitumor through platelet derived growth factor receptor (PDGFR) TK inhibition.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Cancer
Intervention  ICMJE Drug: AG 6013736
5 mg po bid
Study Arms  ICMJE Experimental: 1
Intervention: Drug: AG 6013736
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2008)
3
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

To be eligible for the study, subjects must satisfy all the following criteria:

  1. Histologically documented thyroid cancer with metastases.
  2. Failure of 131I to control the disease or 131I is not an appropriate therapy (eg, due to lack of iodine uptake by the tumor).
  3. No expectation of further effects of prior anticancer therapy.
  4. At least 1 target lesion, as defined by RECIST (Appendix C), that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease assuming all other criteria are met. All target lesions must have a unidimensional diameter of at least 2 cm. (1 cm is acceptable for spiral CT scans if the reconstruction algorithm is 0.5 cm). Baseline measurements/evaluations must be completed within 4 weeks prior to treatment.
  5. Adequate bone marrow, hepatic, and renal function documented within 14 days prior to treatment as documented by:

    • Absolute neutrophil count (ANC, calculated as the absolute number of neutrophils and bands) ?1.5 x 109 cells/L
    • Platelets ?100 x 109 cells /L
    • 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 <2+ by urine dipstick. If dipstick is ?2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours
  6. Age ?18 years.
  7. ECOG performance status of 0 or 1 (see Appendix D)
  8. 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.
  9. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment.
  10. Written and voluntary informed consent.

Exclusion Criteria

Subjects with one or more of the following criteria are ineligible for this study:

  1. Central lung lesions involving major blood vessels (arteries or veins). (Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
  2. History of hemoptysis
  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, or inhibitors of epidermoid growth factor (EGF), platelet derived growth factor (PDGF), or fibroblast growth factors (FGF) receptors.
  5. Current use or anticipated inability to avoid use of 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 inability to avoid use of 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.
  8. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
  9. 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
  10. Major surgical procedure or any radiation therapy within 4 weeks of treatment.
  11. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
  12. Patients (male and female) having procreative potential who are not using adequate contraception or practicing abstinence
  13. Women who are pregnant or breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00176748
Other Study ID Numbers  ICMJE UMCC 2005-036
HUM 216
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer A4061014 - AG 013736 Study Katherine Liau, Pfizer, inc.and parexel, Int'l is the cro
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Francis Worden, M.D.University of Michigan Rogel Cancer Center
PRS Account University of Michigan Rogel Cancer Center
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP