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

Completed · Phase 2

Conditions studied: Carcinoid Tumor

In brief

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.

Key facts

Study ID: NCT00328497
Run by: CASI pharmaceuticals, Inc.
People needed: 31
Starts: 2006-05-01
Expected to finish: 2009-12-01
Last updated by the study team: 2010-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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