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View Clinical Trial (Medical Research Study)
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Octreotide and Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor - NCT00569127-61637 (Clinical Trial 193703)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy193703.aspx
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| City: |
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Peoria |
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State:
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IL |
| Zip Code: |
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61637 |
| Conditions: |
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Neuroendocrine Carcinoma |
| Purpose: |
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RATIONALE: Octreotide and interferon alfa-2b may interfere with the growth of tumor cells
and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, can block tumor
growth in different ways. Some block the ability of tumor cells to grow and spread. Others
find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet
known whether giving octreotide together with interferon alfa-2b is more effective than
giving octreotide together with bevacizumab in treating patients with neuroendocrine tumor.
PURPOSE: This randomized phase III trial is studying giving octreotide together with
interferon alfa-2b to see how well it works compared with giving octreotide together with
bevacizumab in treating patients with metastatic or locally advanced, high-risk
neuroendocrine tumor.
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| Study summary: |
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OBJECTIVES:
- To compare central review-based progression-free survival (PFS) in poor prognosis
carcinoid patients treated with either depot octreotide acetate plus bevacizumab or
depot octreotide acetate plus interferon.
- To compare overall survival, time to treatment failure, and traditionally reported
progression-free survival of poor prognosis carcinoid patients treated with either
depot octreotide acetate plus bevacizumab or depot octreotide acetate plus interferon.
- To compare objective response (confirmed and unconfirmed complete and partial response)
in poor prognosis carcinoid patients treated with either depot octreotide acetate plus
bevacizumab or depot octreotide acetate plus interferon.
- To compare the toxicity profile of these two regimens in these patients.
- To assess the prognostic and predictive value of VEGF expression in relation to PFS and
treatment effect.
- To compare response of 5HIAA, chromogranin A, and neurospecific enolase among patients
with elevated levels at baseline between patients treated with octreotide acetate plus
interferon versus octreotide acetate plus bevacizumab.
- To assess and compare the prognostic and predictive value of the combination of IN-111
pentetreotide somatostatin-receptor scintigraphy (SRS) and CT scan vs. CT scan alone in
relation to PFS.
- To assess and compare the prognostic and predictive value of the combination of SRS and
CT scan vs CT scan alone in relation to overall survival and time to treatment failure.
OUTLINE: This is a multicenter study. Patients are stratified according to site of disease
(small bowel vs cecum vs appendix vs other site), disease progression after initial
diagnosis (yes or no), histologic grade (low vs intermediate [atypical]), and prior
octreotide acetate therapy within the past 2 months (yes vs no). Patients are randomized to
1 of 2 treatment arms.
- Arm I (octreotide acetate and bevacizumab): Patients receive depot octreotide acetate
intramuscularly (IM) and bevacizumab IV over 30-90 minutes on day 1.
- Arm II (octreotide acetate and interferon alfa-2b): Patients receive octreotide acetate
IM as in arm I on day 1 and interferon alfa-2b subcutaneously (SC) on days 1, 3, 5, 8,
10, 12, 15, 17, and 19.
Treatment in both arms repeats every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 2-6 months for up to 3
years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
- Diagnosis of unresectable metastatic or locally advanced, low- or intermediate-grade
neuroendocrine carcinoma, including the following subtypes:
- Carcinoid tumor, low-grade or well differentiated neuroendocrine carcinoma
- Atypical carcinoid tumor, intermediate-grade or moderately differentiated
neuroendocrine carcinoma
- High-risk disease as defined by at least one of the following:
- Progressive disease
- Refractory carcinoid syndrome while receiving octreotide acetate (i.e., defined
by > 2 flushing episodes/day or > 4 bowel movements/day)
- Atypical histology and more than 6 lesions
- Metastatic colorectal carcinoid tumor
- Patients with metastatic cecal or appendiceal carcinoid tumor are not
eligible unless they fit other mentioned high-risk features
- Metastatic gastric carcinoid tumor
- Measurable disease
- Patients with poorly differentiated neuroendocrine carcinoma, high-grade
neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are
not eligible
Exclusion criteria:
- Osseous metastasis as only site of disease
- Medullary thyroid carcinoma or islet cell carcinoma
- History of primary brain tumor or metastatic cancer to the brain
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Zubrod performance status 0-2
- Platelet count > 100,000/mm³
- ANC > 1,500/mm³
- Hemoglobin > 8 g/dL
- Serum bilirubin < 1.5 times upper limit of normal (ULN)
- SGOT and SGPT ≤ 2.5 times ULN
- Serum creatinine < 1.5 mg/dL
- 24-hour urine protein < 1,000 mg if urine protein:creatinine ratio > 0.5
- PT and PTT ≤ 1.1 times ULN
- History of hypertension must be well controlled (i.e., blood pressure < 150/90 mm Hg)
on a stable regimen of antihypertensive therapy
- Not pregnant or nursing
- Fertile patients must use effective barrier method contraception during and for 6
months after completion of study treatment
Exclusion criteria:
- History or evidence of clinically significant peripheral vascular disease (e.g.,
non-healing peripheral ulcers or claudication)
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days
- Bleeding diathesis or coagulopathy that results in spontaneous bleeding (in the
absence of trauma) requiring red blood cell transfusion within the past 5 years
- Serious (i.e., requiring active medical therapy with medication or medical device
under the supervision of a physician) non-healing wound, ulcer, or bone fracture
- Recent history (i.e., within the past 6 months) of any of the following arterial
thromboembolic events:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina
- Myocardial infarction
- New York Heart Association class II or higher congestive heart failure
- Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia
- Pregnant or nursing
- Any other prior malignancy within the past 5 years except for adequately treated
basal cell or squamous cell skin cancer, or other adequately treated in situ cancer
- Any immunologically mediated disease, including any of the following:
- Inflammatory bowel disease (Crohn disease, ulcerative colitis)
- Rheumatoid arthritis
- Idiopathic thrombocytopenia purpura
- Systemic lupus erythematosus
- Autoimmune hemolytic anemia
- Scleroderma
- Severe psoriasis
- Any serious intercurrent infections or nonmalignant medical illnesses that are
uncontrolled or whose control may be jeopardized by the complications of this
treatment
- Psychiatric disorders rendering patient incapable of complying with the requirements
of the protocol
PRIOR CONCURRENT THERAPY:
- Recovered from all prior therapy
- At least 28 days since and no more than 1 prior regimen of cytotoxic chemotherapy
- At least 28 days since prior hepatic artery embolization provided there is residual
measurable disease
- Chemoembolization is considered as 1 prior chemotherapy regimen
- No prior interferon, bevacizumab, or any other therapy targeting VEGF or VEGF
receptors (e.g., SU11248, PTK/ZK, sorafenib tosylate, or pazopanib hydrochloride)
- Prior therapy targeting c-kit, abl, PDGFR, mTOR, and somatostatin receptors allowed
- At least 28 days since prior radiotherapy
- Target lesions must have show disease progression if therapy included peptide
receptor radiotherapy
- At least 1 week since prior minor surgery
- At least 4 weeks since prior major surgery
- At least 21 days since prior octreotide acetate therapy
- Concurrent full-dose anticoagulation (warfarin or low molecular weight heparin)
allowed provided the following criteria are met:
- In-range INR (e.g., between 2 and 3) on a stable dose of oral anticoagulant or
on a stable dose of low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of
bleeding (e.g., varices)
- No concurrent interferon to control carcinoid syndrome for patients receiving
bevacizumab
- Other supportive care medication (e.g., short acting octreotide acetate) allowed
- No other concurrent chemotherapy, immunotherapy, radiotherapy, hepatic artery
embolization, hepatic artery chemoembolization, radiofrequency ablation, or other
tumor ablative procedure
- No other investigational or commercial agents |
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| Study is available at: |
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OSF St. Francis Medical Center
Peoria, IL 61637
United States
Primary Contact:
John W. Kugler, MD
Phone: 309-243-3605 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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August 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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