Gastrointestinal Carcinoid TumorPhase 2NCT00227773
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors
A Phase 2 study testing octreotide acetate, vatalanib and anti-cytokine therapy in people with Gastrointestinal Carcinoid Tumor and Islet Cell Carcinoma, run by Eastern Cooperative Oncology Group.
Trial summary
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control symptoms, such as diarrhea, caused by the tumor. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Gastrointestinal Carcinoid Tumor, Islet Cell Carcinoma
- What is being tested?
- octreotide acetate, vatalanib and anti-cytokine therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed low-grade neuroendocrine tumors
- The following tumor types are excluded:
- Small cell lung cancer
- Medullary thyroid cancer
- Paraganglioma
- Pheochromocytoma
- Measurable disease
- Radiographic evidence of disease progression after completion of any prior systemic therapy, chemoembolization, bland embolization, or observation within the past year, defined as either of the following:
- Appearance of a new lesion
- At least 20% increase in the longest diameter (LD) of any previously documented lesion or an increase in the sum of the LDs of multiple lesions in the aggregate of 20%
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
Hepatic
- Bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
Renal
- Creatinine ≤ 1.5 times ULN
- Meets 1 of the following criteria:
- Urine protein negative by dipstick
- Urine protein:creatinine ratio < 1.0
- Urine protein < 1 g by 24-hour urine collection
Gastrointestinal
- Must be able to swallow tablets
- No ulcerative disease
- No uncontrolled nausea, vomiting, or diarrhea
- No bowel obstruction
- No other gastrointestinal tract disease resulting in an inability to take oral medication
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be able to receive a contrast-enhanced CT scan
- No known history of allergic reaction to vatalanib or its derivatives or octreotide injections
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since prior chemotherapy
- No more than 1 prior systemic chemotherapy regimen
- Chemoembolization is not considered systemic chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- At least 4 weeks since prior major surgery
Other
- At least 4 weeks since other prior systemic therapy
- At least 4 weeks since prior local liver therapy
- No prior anti-vascular endothelial growth factor agents
- No concurrent grapefruit or grapefruit juice
- No concurrent therapeutic warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system
- Concurrent heparin allowed
About this study
Official title: Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide may be an effective treatment for neuroendocrine tumors.
PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors.
Read the detailed description
OBJECTIVES:
- Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide.
- Determine the response rate in patients treated with this regimen.
- Determine the effect of this regimen on tumor markers (e.g., chromogranin A, 5-HIAA, and gastrin) in these patients.
- Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral vatalanib once daily on days 1- 28 and octreotide* intramuscularly or IV on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients on a stable dose (i.e., no changes in dosage within the past 3 months) of octreotide before study entry remain on their current dose and schedule during study participation; patients who experience hypersensitivity and/or toxicity to octreotide may receive vatalanib alone.
After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 3 years.
- Being tested
- octreotide acetate, vatalanib, anti-cytokine therapy, antiangiogenesis therapy, biological therapy
- Keywords
- localized gastrointestinal carcinoid tumor, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, recurrent islet cell carcinoma, gastrinoma, insulinoma, WDHA syndrome, glucagonoma, pancreatic polypeptide tumor, somatostatinoma
- Medical subject headings
- Carcinoma, Islet Cell, Gastrinoma, Insulinoma, Vipoma, Glucagonoma, Somatostatinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octreotide acetateDrug
vatalanibDrug
anti-cytokine therapyProcedure or surgery
antiangiogenesis therapyProcedure or surgery
biological therapyProcedure or surgery
endocrine therapyProcedure or surgery
enzyme inhibitor therapyProcedure or surgery
growth factor antagonist therapyProcedure or surgery
hormone therapyProcedure or surgery
protein tyrosine kinase inhibitor therapyProcedure or surgery
somatostatin analogue therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Carcinoid TumorStudies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Kyle Holen, MD, Study chair, University of Wisconsin, MadisonMary Mulcahy, MD, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227773
- Sponsor's protocol ID
- CDR0000446076
- Other IDs
- ECOG-E6203
- Status last verified
- Oct 2015
- First submitted
- 26 Sep 2005
- Last updated
- 8 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00227773
- Acronym / sponsor ID
- CDR0000446076
- Keywords
- localized gastrointestinal carcinoid tumor, metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, regional gastrointestinal carcinoid tumor, recurrent islet cell carcinoma, gastrinoma, insulinoma, WDHA syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 28 Sep 2005 (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.
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide may be an effective treatment for neuroendocrine tumors.
PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors.
Detailed description
OBJECTIVES:
- Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide.
- Determine the response rate in patients treated with this regimen.
- Determine the effect of this regimen on tumor markers (e.g., chromogranin A, 5-HIAA, and gastrin) in these patients.
- Determine the toxicity and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral vatalanib once daily on days 1- 28 and octreotide* intramuscularly or IV on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients on a stable dose (i.e., no changes in dosage within the past 3 months) of octreotide before study entry remain on their current dose and schedule during study participation; patients who experience hypersensitivity and/or toxicity to octreotide may receive vatalanib alone.
After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| octreotide acetate | Drug | – |
| vatalanib | Drug | – |
| anti-cytokine therapy | Procedure or surgery | – |
| antiangiogenesis therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| endocrine therapy | Procedure or surgery | – |
| enzyme inhibitor therapy | Procedure or surgery | – |
| growth factor antagonist therapy | Procedure or surgery | – |
| hormone therapy | Procedure or surgery | – |
| protein tyrosine kinase inhibitor therapy | Procedure or surgery | – |
| somatostatin analogue therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
Kyle Holen, MD study chair
University of Wisconsin, Madison
Mary Mulcahy, MD
Robert H. Lurie Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing octreotide acetate, vatalanib and anti-cytokine therapy in people with Gastrointestinal Carcinoid Tumor and Islet Cell Carcinoma, run by Eastern Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 8 Oct 2015.