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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.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00328497
First received: May 18, 2006
Last updated: March 9, 2010
Last verified: March 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors [ Time Frame: Approximately every 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328497

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

No publications provided

Responsible Party: Carolyn F. Sidor, MD, MBA; Chief Medical Officer, EntreMed, Inc.
ClinicalTrials.gov Identifier: NCT00328497     History of Changes
Other Study ID Numbers: ME-CLN-002
Study First Received: May 18, 2006
Last Updated: March 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoid Tumor
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
2-methoxyestradiol
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014