Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer

Completed · Phase 2

Conditions studied: Adrenal Cortex Neoplasms

In brief

Background: \- Adrenocortical carcinoma is an aggressive cancer that starts in the adrenal gland at the top of the kidneys. It has a low survival rate if standard treatment options are not effective. Axitinib is an experimental drug that is being studied to determine if it can stop tumors from growing or make them smaller. Researchers are interested in investigating axitinib in individuals with aggressive or otherwise untreatable adrenocortical cancer. Objectives: \- To evaluate the effectiveness of axitinib in individuals who have adrenocortical cancer that is inoperable and has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with adrenocortical cancer that has not responded to standard treatments. Design: * Participants will be screened with a full physical examination and medical history, as well as tumor imaging studies. * Participants may have a tumor biopsy prior to starting axitinib. * All participants will receive axitinib to take twice a day with food for 28 days (1 cycle). Participants should not drink grapefruit juice or smoke cigarettes while participating in this study. * After the first cycle, the dose may be increased and additional cycles will be given if the treatment has not had serious side effects. * Participants will have regular examinations while taking axitinib, including blood samples and tumor imaging studies to determine if the tumor has stopped growing. Blood pressure levels will be carefully monitored during treatment to evaluate potential risk for high blood pressure. * Participants may have a second tumor biopsy 20 to 30 days after treatment begins. * Treatment will continue as directed by the study researchers.

Key facts

Study ID

NCT01255137

Run by

National Cancer Institute (NCI)

People needed

13

Starts

2010-09-01

Expected to finish

2012-12-01

Last updated by the study team

2013-06-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with adrenocortical tumors potentially curable by surgical excision alone as determined by the Principal Investigator in discussions with the surgical consultants.
• Patients who have large abdominal masses impinging on bowel or pulmonary masses with encroached vessels and a potential to bleed will be considered on case by case basis after careful consultation with multiple disciplines such as radiologists and surgeons with main intent being patient safety.
• Unstable hypertension defined as a systolic blood pressure greater than 140 mm Hg or diastolic pressure greater than 90 mmHg despite optimal medical management and patients who are receiving more than 1 antihypertensive agent at trial entry, (not including spironolactone) unless the patient has Cushing's Disease with its associated hypertension and is well controlled on medications.
• Untreated brain metastases (or local treatment of brain metastases within the last 6 months) due to the poor prognosis of these patients and difficulty ascertaining the cause of neurologic adverse events.
• Pregnancy, due to the possible adverse effects on the developing fetus.
• Lactating women who are breast-feeding due to the possibility of transmitting axitinib to the child.
• The presence of a second malignancy, other than a skin cancer or in situ cervical cancer because it will complicate the primary objective of the study. Cancer survivors who have been free of disease for at least two years can be enrolled in this study.
• Patients with evidence of a bleeding diathesis.
• Phosphorus level equal to, or less than, the institutional lower limits of normal that cannot be corrected.
• Gastrointestinal abnormalities including:
• inability to take oral medications
• requirement for intravenous alimentation
• prior surgical procedure affecting absorption including total 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 syndrome
• Current use or anticipated need for treatment with drugs that are known potent cytochrome P450 3A4 (CYP3A4) inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, and delavirdine).
• Current use or anticipated need for treatment with drugs that are known CYP3A4 inducers (i.e., carbamazepine, Phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).
• Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
• Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
• Any of the following within 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
• Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
• Current use of drugs that are known inhibitors or inducers of Breast Cancer Resistance Protein (BCRP) and Organic Anion Transporting Polypeptide (OATP)1B1/3 or known to affect protein binding should be used with caution and with acknowledgement of the principal investigator (PI).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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