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

Primary Purpose

Carcinoid Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)
Sponsored by
CASI Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm 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

Outcomes

Primary Outcome Measures

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
To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors
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

Secondary Outcome Measures

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
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

Full Information

First Posted
May 18, 2006
Last Updated
March 9, 2010
Sponsor
CASI Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00328497
Brief Title
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

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CASI Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)
Intervention Description
Panzem NCD 1,000 mg, four times daily for 28 consecutive days bevacizumab 5 mg/kg intravenous bolus on Day 1 and Day 15
Primary Outcome Measure Information:
Title
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
Time Frame
Approximately monthly
Title
To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors
Time Frame
Approximately every 8 weeks
Title
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
Time Frame
Approximately every 3 months
Secondary Outcome Measure Information:
Title
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
Time Frame
Approximately every 3 months
Title
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
Time Frame
Approximately monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew H. Kulke, M.D.
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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