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

This study has been completed.
Information provided by:
CASI Pharmaceuticals, Inc. Identifier:
First received: May 18, 2006
Last updated: March 9, 2010
Last verified: March 2010
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.

Condition Intervention Phase
Carcinoid Tumor
Drug: Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by CASI Pharmaceuticals, Inc.:

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 [ Time Frame: Approximately monthly ]
  • To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors [ Time Frame: Approximately every 8 weeks ]
  • 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 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 [ Time Frame: Approximately every 3 months ]
  • 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 ]

Enrollment: 31
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Drug: Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)
Panzem NCD 1,000 mg, four times daily for 28 consecutive days bevacizumab 5 mg/kg intravenous bolus on Day 1 and Day 15


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00328497

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Principal Investigator: Matthew H. Kulke, M.D. Dana-Farber Cancer Institute
  More Information

Responsible Party: Carolyn F. Sidor, MD, MBA; Chief Medical Officer, EntreMed, Inc. Identifier: NCT00328497     History of Changes
Other Study ID Numbers: ME-CLN-002
Study First Received: May 18, 2006
Last Updated: March 9, 2010

Additional relevant MeSH terms:
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017