A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CASI Pharmaceuticals, Inc.
• Treatments: 2-Methoxyestradiol; Bevacizumab

Criteria

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