Metastatic Neuroendocrine TumorsPhase 2PTK787NCT00590343
Safety and Efficacy Study of PTK787/ZK222584 to Treat Metastatic Neuroendocrine Tumors
A Phase 2 study testing vatalanib in people with Metastatic Neuroendocrine Tumors, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Neuroendocrine Tumors
- What is being tested?
- vatalanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
- Symptomatic congestive heart failure
- Myocardial infarction <or= 6 months prior to registration
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Phase II Study Evaluating the Safety and Efficacy of PTK787/ZK222584 in Patients With Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms.
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.
Read the detailed description
This is an open-label, phase II study evaluating the safety and efficacy of PTK787/ZK222584 administered daily in subjects with neuroendocrine tumors that are experiencing progressive disease and/or whose tumor-related syndrome symptoms (flushing and diarrhea) are considered inadequately controlled despite optimal doses of octreotide therapy. Inadequate control is defined as a minimum of 2 flushing episodes or 6 bowel movements per day for 7 consecutive days. Subjects who meet all inclusion and exclusion criteria and have completed all baseline and screening testing will receive an initial dose of PTK787/ZK222584 1,250 mg once daily and subjects will also remain on the scheduled doses of Sandostatin LAR 30 mg every 4 weeks. Both drugs will be dosed on a flat schedule of mg, not by weight or body surface area. The PTK787/ZK222584 medication will be taken orally with daily dosing. Each tablet of PTK787/ZK 222584 is 250 mg. The subject will take five tablets of study medication per day 2 tabs am and 3 tabs pm. Subjects may continue to receive therapy as long as they do not experience unacceptable toxicities or evidence of disease progression as defined by RECIST criteria. Subjects will be evaluated with a daily log to assess the degree of symptom control (flushing and diarrhea) and subjects will be monitored every 2 weeks for 3 months then monthly for biochemical control and every three months for tumor response. Subjects will be monitored by the Investigator every two weeks for 3 months then monthly for safety and efficacy.
- Conditions
- Metastatic Neuroendocrine Tumors
- Being tested
- vatalanib
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vatalanibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: vatalanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biochemical markers.
Measured: Quarterly= every 3 months
Secondary outcomes (1)
Tumor response per triphasic CT scan.
Measured: Quarterly= every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startNov 2004
- Primary completionMar 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Lowell B Anthony, MD, Principal investigator, Lousiana State University Health Sciences Center-NO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590343
- Sponsor's protocol ID
- PTK787/ZK222584
- Other IDs
- LSU IRB-6355
- Acronym
- PTK787
- Status last verified
- Jun 2011
- First submitted
- 26 Dec 2007
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12124335
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase II Study Evaluating the Safety and Efficacy of PTK787/ZK222584 in Patients With Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms.
- ClinicalTrials.gov ID
- NCT00590343
- Acronym / sponsor ID
- PTK787 / PTK787/ZK222584
- Conditions
- Metastatic Neuroendocrine Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, phase II study evaluating the safety and efficacy of PTK787/ZK222584 administered daily in subjects with neuroendocrine tumors that are experiencing progressive disease and/or whose tumor-related syndrome symptoms (flushing and diarrhea) are considered inadequately controlled despite optimal doses of octreotide therapy. Inadequate control is defined as a minimum of 2 flushing episodes or 6 bowel movements per day for 7 consecutive days. Subjects who meet all inclusion and exclusion criteria and have completed all baseline and screening testing will receive an initial dose of PTK787/ZK222584 1,250 mg once daily and subjects will also remain on the scheduled doses of Sandostatin LAR 30 mg every 4 weeks. Both drugs will be dosed on a flat schedule of mg, not by weight or body surface area. The PTK787/ZK222584 medication will be taken orally with daily dosing. Each tablet of PTK787/ZK 222584 is 250 mg. The subject will take five tablets of study medication per day 2 tabs am and 3 tabs pm. Subjects may continue to receive therapy as long as they do not experience unacceptable toxicities or evidence of disease progression as defined by RECIST criteria. Subjects will be evaluated with a daily log to assess the degree of symptom control (flushing and diarrhea) and subjects will be monitored every 2 weeks for 3 months then monthly for biochemical control and every three months for tumor response. Subjects will be monitored by the Investigator every two weeks for 3 months then monthly for safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vatalanibIntervention=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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vatalanibSubjects 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. | Drug | 1 |
Primary outcome
Change in biochemical markers.
Time frame: Quarterly= every 3 months
1 secondary outcome
Tumor response per triphasic CT scan.
Time frame: Quarterly= every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Background: PubMed 12124335Drevs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lowell B Anthony, MD principal investigator
Lousiana State University Health Sciences Center-NO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vatalanib in people with Metastatic Neuroendocrine Tumors, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biochemical markers. (time frame: Quarterly= every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00590343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.