Overview

Safety and Efficacy Study of PTK787/ZK222584 to Treat Metastatic Neuroendocrine Tumors

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine if PTK787/ZK222584 (vatalanib) will stabilize or decrease rising biochemical markers along with progressive disease or syndrome symptoms in patients with metastatic neuroendocrine tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Collaborator:
Novartis
Treatments:
Vatalanib
Criteria
Inclusion Criteria:

- Biopsy-proven metastatic neuroendocrine tumors (which extent is disease is determined
by CT scan or MRI) and biochemical evidence of disease.

- Evidence of progressive disease or inadequate controlled disease related syndrome
symptoms.

- Must be receiving Sandostatin LAR 30mg every 4 weeks

- Age >or= to 18 years old

- Karnofsky Performance Status > or = 60

- Measurable lesion(s) as per the modified RECIST criteria

- Laboratory values or= 1.5 x 10(9)/L,
Platelets >or= 100 x 10 (9), Hemoglobin >or= 9g/dL, Serum creatinine Serum bilirubin aminotransferase (ALT/SGPT) Negative for proteinuria based on dip stick reading OR documentation of 1+ result for
protein on dip stick reading, then total urinary protein creatinine clearance >or= 50ml/min from a 24 hour urine collection.

- Life expectancy >or= 12 weeks.

- Written informed consent obtained according to local guidelines.

Exclusion Criteria:

- Had previous radiolabeled somatostatin analog therapy within the last 6 months.

- Hepatic artery embolization within the last 6 months (1 month if there are other sites
of measurable disease)

- Undergone cryoablation of hepatic metastasis within the last 2 months.

- History or presence of central nervous system (CNS) disease (ie:primary brain tumor,
malignant seizures, CNS metastases or carcinomatous meningitis)

- History of another primary malignancy basal or squamous cell carcinoma of the skin.

- Prior chemotherapy must have recovered from all therapy-related toxicities.

- Prior biologic or immunotherapy randomization. Patients must have recovered from all therapy-related toxicities.

- Prior full field radiotherapy prior to randomization. Patients must have recovered from all therapy-related
toxicities. The site of previous radiotherapy should have evidence of progressive
disease if this is the only site of disease.

- Major surgery (ie:laparotomy) 2 weeks prior to randomization. Insertion of a vascular access device is not
considered major or minor surgery in this regard. Patients must have recovered from
all surgery-related toxicities.

- Patients who have received investigational drugs
- Prior therapy with anti-VEGF agents

- Pleural effusion or ascites that causes respiratory compromise (>or= CTC grade 2
dyspnea)

- Female patients who are pregnant or breast feeding or adults of reproductive potential
not employing an effective method of birth control. Barrier contraceptives must be
used throughout the trial in both sexes. Oral, implantable, or injectable
contraceptives may be affected by cytochrome P450 interactions, therefore not
considered effective for this study. Women of childbearing potential must have a
negative serum pregnancy test 48 hours prior to administration of study treatment.

- Uncontrolled high blood pressure, history of labile hypertension, or history of poor
compliance with an antihypertensive regimen.

- Unstable angina pectoris

- Symptomatic congestive heart failure

- Myocardial infarction
- Active or uncontrolled infection

- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

- Chronic renal disease

- Subjects at risk of significant cardiac arrythmias

- Uncontrolled diabetes

- Acute or chronic liver disease (eg:hepatitis, cirrhosis)

- Impairment of gastrointestinal function or GI disease that may significantly alter
absorption (ie:ulcerative disease, uncontrolled nausea, vomiting, diarrhea,
malabsorption syndrome, bowel obstruction, or inability to swallow the tablets.)

- Confirmed diagnosis of human immunodeficiency syndrome (HIV) infection are excluded at
the investigator's discretion.

- Patients taking therapeutic warfarin sodium (Coumadin) or similar oral anticoagulants
that are metabolized by the cytochrome P450 system. Heparin is allowed.

- Patients unwilling or unable to comply with the protocol.

- Known symptomatic gallstones

- Received glucocorticoid therapy within the past 6 months, or who are currently
receiving any chemotherapeutic agents, insulin sensitizers (eg:metformin,
pioglitazone, rosiglitazone), or exogenous growth hormones.

- Subjects with unacceptable concomitant diagnoses, or who have received medication
and/or therapies (ie:illness or therapies that would place patient at increased risk,
or would, in the opinion of the investigator, interfere with the evaluation of
efficacy or safety.)

- Exhibit symptoms indicative of intolerance of Sandostatin LAR.