Treatment for Patients With Metastatic Thyroid Cancer

NCT00176748 | Completed Phase 2

• 2 other identifiers: UMCC 2005-036HUM 216
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine the response rate of AG-013736 in patients with metastatic thyroid cancer (who are refractory to or not suitable candidates for 131I treatment).

  Approximately 2 years

Secondary Outcomes (5)

• To determine the safety profile of AG-013736

  Approximately 2 years

• To determine the progression-free survival

  This is a variable in the outcome measure (time frame cannot be determined).

• To determine the duration of response.

  The time frame cannot be determined as it is the variable that is being studied for this Outcome Measure.

• To determine overall survival.

  Time Frame cannot be approximated as this is the variable that is being studied in this Outcome Measure.

• To obtain blood samples for population pharmacokinetic analyses in order to explore relationships between clinical response and plasma soluble proteins.

  2 years

Study Arms (1)

1

EXPERIMENTAL

Drug: AG 6013736

Interventions

AG 6013736 DRUG

5 mg po bid

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the study, subjects must satisfy all the following criteria:
• Histologically documented thyroid cancer with metastases.
• Failure of 131I to control the disease or 131I is not an appropriate therapy (eg, due to lack of iodine uptake by the tumor).
• No expectation of further effects of prior anticancer therapy.
• 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.
• 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
• Age ≥18 years.
• ECOG performance status of 0 or 1 (see Appendix D)
• 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.

You may not qualify if:

• Subjects with one or more of the following criteria are ineligible for this study:
• 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.)
• History of hemoptysis
• 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.
• 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.
• 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).
• 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).
• Active seizure disorder or evidence of brain metastases.
• A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Francis Worden, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: June 1, 2009
• Last Updated: January 15, 2010

Record last verified: 2010-01

Locations

US (1)