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| ID | Type | Description | Link |
|---|---|---|---|
| GA6181079 | Other Identifier | Pfizer |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.
This is a single-center, open-label, non-randomized, prospective phase II trial. Sutent treatment will be continued until disease progression, or excessive toxicity (as determined by treating physician or primary investigator), or until a maximum of eight cycles, whichever duration is shorter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib Malate and Hepatic Artery Embolizations | Experimental | Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib malate | Drug | Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks. No fewer than seven days shall separate treatment with Sutent and scheduling of hepatic artery embolizations. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) at 12 Months | Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Survival (OS) at One Year | Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. | 12 months |
| Number of Participants With Partial Radiographic Response |
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Inclusion Criteria:
Well-differentiated metastatic carcinoid tumors and pancreatic endocrine tumors with measurable liver metastases.
Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 grade less than or equal to 1.
Adequate organ function as defined by the following criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2
Informed Consent: Patients must be aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Strosberg, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials Website | View source |
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All patients seen at Moffitt Cancer Center with hepatic metastases from gastrointestinal neuroendocrine tumors were screened for eligibility to be enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib Malate and Hepatic Artery Embolizations | Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib Malate and Hepatic Artery Embolizations | Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Progression Free Survival (PFS) at 12 Months | Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started. | All participants | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib Malate and Hepatic Artery Embolizations | Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage, GI - Recturm - possibly related | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Strosberg, M.D. | H. Lee Moffitt Cancer Center and Research Institute | 813-745-7257 | jonathan.strosberg@moffitt.org |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D007516 | Adenoma, Islet Cell |
| D002276 | Carcinoid Tumor |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Hepatic Artery Embolizations | Procedure | 1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor. |
|
Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD. |
| 12 months |
| Number of Participants With Biochemical Response | Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases. | 12 months |
| Number of Participants Requiring Dose Reduction | Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects. | 12 months |
| Percentage of Participants With Overall Survival (OS) at 4 Years | Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. | 48 months |
| had embolism, did not receive sunitinib |
|
| Participants |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percentage of Participants With Overall Survival (OS) at One Year | Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. | All participants | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Secondary | Number of Participants With Partial Radiographic Response | Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD. | All Participants | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Number of Participants With Biochemical Response | Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases. | All Participants | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Number of Participants Requiring Dose Reduction | Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects. | All participants | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Percentage of Participants With Overall Survival (OS) at 4 Years | Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. | All Participants | Posted | Number | 95% Confidence Interval | percentage of participants | 48 months |
|
|
|
| 3 |
| 39 |
| 38 |
| 39 |
| Nausea and Vomiting - unrelated | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Dysphagia - unrelated | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Anorexia - unrelated | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Obstruction, GI - Gallbladder - unrelated | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Obstruction, GI - Small bowel - unrelated | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Neutrophils/granulocytes | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
|
| Back pain | General disorders | CTC V3 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
|
| Epistaxis | General disorders | CTC V3 | Systematic Assessment |
|
| Fatigue | General disorders | CTC V3 | Systematic Assessment |
|
| Fever | General disorders | CTC V3 | Systematic Assessment |
|
| Hair loss | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
|
| Headache | General disorders | CTC V3 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTC V3 | Systematic Assessment |
|
| Mood alterations | General disorders | CTC V3 | Systematic Assessment |
|
| Mucositis/stomatitis | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTC V3 | Systematic Assessment |
|
| Potassium | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
|
| Rhinitis | General disorders | CTC V3 | Systematic Assessment |
|
| Taste alterations | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
| Weitht loss | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
|
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| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |