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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoid Tumor

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Approximately monthly

Safety Issue:

Yes

Principal Investigator

Matthew H. Kulke, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

ME-CLN-002

NCT ID:

NCT00328497

Start Date:

May 2006

Completion Date:

December 2009

Related Keywords:

  • Carcinoid Tumor
  • Carcinoid Tumor

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115