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

CASI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Carcinoid Tumor

Treatments: Drug: Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00328497

ME-CLN-002

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

1

Experimental group

Description:

Panzem NCD will be dosed orally at a level of 1,000 mg, four times daily for 28 consecutive days and bevacizumab will be administered at a dose of 5 mg/kg as an intravenous bolus on Day 1 and Day 15 of the Treatment Period

Treatment:

Drug: Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)