Carcinoid Tumor
Conditions
Brief summary
This single center, open-label study will evaluate the safety and efficacy of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Dispersion (NCD) administered orally with recombinant human monoclonal antibody against vascular endothelial growth factor (bevacizumab) administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.
Interventions
DRUGPanzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)
Panzem NCD 1,000 mg, four times daily for 28 consecutive days bevacizumab 5 mg/kg intravenous bolus on Day 1 and Day 15
Sponsors
CASI Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically documented locally unresectable or metastatic carcinoid neuroendocrine tumor * Measurable disease, according to RECIST, with at least one lesion that is unidimensionally measurable by conventional techniques to be greater than or equal to 2 cm in diameter, or by spiral CT to be greater than or equal to 1 cm in diameter * 18 years or older Laboratory data to include (next 7 bullet points): * Aspartate aminotransferase(AST)and alanine aminotransferase (ALT)less than 2.5 times the upper limit of normal (less than 5 times upper limit of normal if liver metastasis present) * Total bilirubin less than or equal to 2 mg/dL * Serum creatinine less than or equal to 1.5 mg/dL * Total white blood cell count greater than 3,500/mm3 * Absolute neutrophil count greater than or equal to 1,500/mm3 * International normalized ratio less then or equal to 1.5 * Platelets greater than or equal to 100,000/mm3 * Agree to use effective contraceptive methods * Have an ECOG performance status of less than 2 * Life expectancy of greater than 12 weeks * Ability to understand the requirements of the study, have provided written consent, and agree to abibe by the study restrictions
Exclusion criteria
* Pregnant or nursing, or refusal to use appropriate birth control * An active infection * Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 12 months (the patient may be on antianginal medications if the symptoms can be fully controlled), or have uncontrolled congestive heart failure * Have apparent central nervous system metastasis or carcinomatous meningitis * Have had any active cancer in addition to the carcinoid tumor within the last 5 years, with the exception of superficial skin cancer * Be receiving concurrent treatment with therapeutic doses of any anticoagulant including all forms of heparin and Coumadin * Have current or a history of severe bleeding * Uncontrolled / severe hypertension * Previous history of nephrotic syndrome * Urine protein: creatinine ratio greater than or equal to 1.0 at screening * Have received radiotherapy or chemotherapy within the previous 4 weeks * Participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks * Have had major surgery within 4 weeks or plan to undergo elective surgery during treatment * Additional uncontrolled serious medical condition or psychiatric illness * Have any condition that is likely to interfere with regular follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of Panzem NCD administered orally in combination with intravenous infusion of bevacizumab by evaluation of the frequency and severity of treatment emergent adverse events | Approximately monthly |
| To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors | Approximately every 8 weeks |
| To determine the overall survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab | Approximately every 3 months |
Secondary
| Measure | Time frame |
|---|---|
| To determine the progression-free survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab | Approximately every 3 months |
| To monitor the steady-state trough plasma levels of 2ME2 following 28-day dosing cycles of Panzem NCD when administered orally in combination with intravenous infusion of bevacizumab | Approximately monthly |
Countries
United States
Outcome results
None listed