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

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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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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

Condition

Carcinoid Tumor

Intervention

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

Study Arms / Comparison Groups

 1
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

31

Start Date

May 2006

Completion Date

December 2009

Primary Completion Date

December 2008

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthew H. Kulke, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00328497

Organization ID

ME-CLN-002



Study Sponsor

CASI Pharmaceuticals, Inc.


Study Sponsor

Matthew H. Kulke, M.D., Principal Investigator, Dana-Farber Cancer Institute


Verification Date

March 2010