Metastatic or locally advanced endometrial cancer not amenable to other therapy
Conditions
Interventions
Pazopanib 800 MG PO continuously until progression, unacceptable toxicity or patient refusal.
Sponsors
University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Age ≥ 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. Histologically or cytologically confirmed diagnosis of endometrial cancer; 5. Metastatic disease or locally advanced tumor not amenable to local therapy; 6. Documented progressive disease before enrolment; 7. Measurable lesions outside irradiated field or progressive measurable lesions in irradiated area; 8. Not eligible for hormonal therapy (because of negative hormone receptor/poor differentiation, or after failure of hormonal therapy); 9. Previous failure of chemotherapy, or refusal to undergo chemotherapy or chemo-naive patients not suitable for chemotherapy; 10. Adequate organ system function.
Exclusion criteria
Exclusion criteria: 1. Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible; 2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, with no radiological signs of progression and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug; 3. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or may affect absorption of investigational product; 4. Presence of uncontrolled infection; 5. Corrected QT interval (QTc) > 480 msecs using Bazett’s formula; 6. History of major cardiovascular conditions within the past 6 months or poorly controlled hypertension, history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible; 7. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major); 8. Evidence of active bleeding or bleeding diathesis; 9. Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients free of progression at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate; 2. Progression free survival; 3. Overall survival; 4. Tolerability/toxicity. | — |
Contacts
Public ContactA.M. Westermann
AMC Dept Medical Oncology
Outcome results
None listed