Clinical trial NCT00328497: A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors
Official title: A Phase 1-2 Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With rhuMAb VEGF (Bevacizumab) in Patients With Locally Advanced or Metastatic Carcinoid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoid Tumor
Lead sponsor: CASI Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Approximately monthly
measure: To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors
timeFrame: Approximately every 8 weeks
measure: 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
timeFrame: Approximately every 3 months
Secondary outcomes:
measure: 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
timeFrame: Approximately every 3 months
measure: 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
timeFrame: Approximately monthly
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew H. Kulke, M.D.
role: PRINCIPAL_INVESTIGATOR
References: