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