Status:
COMPLETED
A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors
Lead Sponsor:
CASI Pharmaceuticals, Inc.
Conditions:
Carcinoid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 antib...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00328497
Start Date
May 1 2006
End Date
December 1 2009
Last Update
March 10 2010
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115