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

NCT00590343 | Completed Phase 2 DMC

• 2 other identifiers: PTK787/ZK222584LSU IRB-6355
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Change in biochemical markers.

  Quarterly= every 3 months

Secondary Outcomes (1)

• Tumor response per triphasic CT scan.

  Quarterly= every 3 months

Study Arms (1)

1

EXPERIMENTAL

Intervention=Patients will receive treatment with PTK787/ZK222584 daily. A treatment cycle will be defined as a 28-day period. Subjects will continue on their present treatment regimen of receiving Sandostatin LAR 30mg IM every 4 weeks.

Drug: vatalanib

Interventions

vatalanib DRUG

Subjects who meet all inclusion and exclusion criteria will receive an initial dose of PTK787/ZK222584 1,250mg once daily, and subjects will remain on the scheduled doses of Sandostatin LAR 30mg every 4 weeks.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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= 2 weeks prior to randomization: ANC \>or= 1.5 x 10(9)/L, Platelets \>or= 100 x 10 (9), Hemoglobin \>or= 9g/dL, Serum creatinine \<or= 1.5 ULN, Serum bilirubin \<or= 1.5 ULN, Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \<or= 3.0 x ULN (\<or= 5 x ULN if liver metastases present), Negative for proteinuria based on dip stick reading OR documentation of 1+ result for protein on dip stick reading, then total urinary protein \<or= 500mg and measured creatinine clearance \>or= 50ml/min from a 24 hour urine collection.
• Life expectancy \>or= 12 weeks.
• Written informed consent obtained according to local guidelines.

You may not qualify if:

• 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 \<or= 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin.
• Prior chemotherapy \<or= 3 weeks prior to registration and/or randomization. Patients must have recovered from all therapy-related toxicities.
• Prior biologic or immunotherapy \<or= 2 weeks prior to registration and/or randomization. Patients must have recovered from all therapy-related toxicities.
• Prior full field radiotherapy \<or= 4 weeks or limited field radiotherapy \<or= 2 weeks 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) \<or= 4 weeks prior to randomization. Minor surgery \<or= 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 \<or= 4 weeks prior to registration.
• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Novartis: collaborator

Study Sites (1)

Neuroendocrine Clinic

Kenner, Louisiana, 70065, United States

Location

Related Publications (1)

• Drevs J, Muller-Driver R, Wittig C, Fuxius S, Esser N, Hugenschmidt H, Konerding MA, Allegrini PR, Wood J, Hennig J, Unger C, Marme D. PTK787/ZK 222584, a specific vascular endothelial growth factor-receptor tyrosine kinase inhibitor, affects the anatomy of the tumor vascular bed and the functional vascular properties as detected by dynamic enhanced magnetic resonance imaging. Cancer Res. 2002 Jul 15;62(14):4015-22.

  PMID: 12124335 BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

vatalanib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Lowell B Anthony, MD

  Lousiana State University Health Sciences Center-NO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: November 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 29, 2011

Record last verified: 2011-06

Locations

US (1)