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