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Active, not recruiting Phase 2

Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

NCT01841736 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 2
Started
2013-09-20
Last updated
2026-10-06

Condition(s) studied

Foregut Neuroendocrine TumorHindgut Neuroendocrine TumorMetastatic Digestive System Neuroendocrine Tumor G1Metastatic Neuroendocrine TumorMidgut Neuroendocrine Tumor G1Neuroendocrine Tumor G2Recurrent Digestive System Neuroendocrine Tumor G1Regional Digestive System Neuroendocrine Tumor G1

Investigational drug(s) / intervention(s)

Biospecimen CollectionComputed TomographyEchocardiography TestLaboratory Biomarker AnalysisMagnetic Resonance ImagingMultigated Acquisition ScanPazopanib Hydrochloride →Placebo AdministrationQuality-of-Life AssessmentX-Ray Imaging

Biospecimen Collection: Undergo blood sample collection

Computed Tomography: Undergo CT

Echocardiography Test: Undergo ECHO

Laboratory Biomarker Analysis: Correlative studies

Magnetic Resonance Imaging: Undergo MRI

Multigated Acquisition Scan: Undergo MUGA

Pazopanib Hydrochloride: Given PO

Placebo Administration: Given PO

Quality-of-Life Assessment: Ancillary studies

X-Ray Imaging: Undergo chest x-ray

Study summary

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes: carcinoid tumor, low- to intermediate-grade or well- to moderately-differentiated neuroendocrine carcinoma or tumor, atypical carcinoid tumor; documentation from a primary tumor or metastatic site is sufficient; patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible * Locally unresectable or metastatic carcinoid tumors * Patients must have histologic documentation or clinical evidence of a carcinoid tumor of primary site (including foregut, midgut, hindgut or other non-pancreatic site); tumors of unknown primary site are eligible provided the treating physician does not suspect medullary thyroid cancer, pancreatic neuroendocrine tumor, paraganglioma, or pheochromocytoma; unknown primary tumors will be classified as small bowel tumors for the purpose of stratification; functional (associated with a clinical syndrome) or nonfunctional tumors are allowed; target lesions must have shown disease progression if therapy included peptide receptor radiotherapy (PRRT) and PRRT must be completed at least 8 weeks prior to registration * Radiological evidence for progressive disease (measurable or non-measurable) within 12 months prior to registration; patients who have received anti-tumor therapy during the past 12 months (including octreotide analogs) must have had radiological documentation of progression of disease while on or after receiving therapy * No known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; patients with lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (computed tomography \[CT\] with contrast is strongly recommended to evaluate such lesions); patients with large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed * Patients must have measurable disease per RECIST 1.1 by computed tomography (CT) scan or magnetic resonance imaging (MRI); lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 1 cm with CT or MRI (or \>= 1.5 cm for lymph nodes); index lesions for the purpose of RECIST 1.1 measurements will not be selected from within the radiation therapy treatment field; however, if there is evidence of disease progression within the radiation treatment field, measurement of the progressing lesions will be documented * No prior treatment with an inhibitor of vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) * Prior treatment (somatostatin analogs excepted) must be completed at least 2 weeks prior to registration; in addition, prior treatment (somatostatin analogs excepted) must be completed at least 4 weeks prior to initiation of study drug; treatment-related toxicities must have improved to =\< grade 1 prior to registration, with the exception of alopecia * Concurrent use of somatostatin analogs (SSTa) is allowed, provided that the patient is on a stable dose for at least two months and progressive disease on somatostatin analog has been documented; progression on octreotide is required for patients with tumors arising in the midgut * Prior treatment with embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or there is documented disease progression in a treated site; there is no limit on the prior number of procedures; prior liver-directed or other ablative treatment must be completed at least 8 weeks prior to registration; index lesions for the purpose of RECIST 1.1 measurements will not be selected from within the radiation therapy treatment field; however, if there is evidence of disease progression within the radiation treatment field, measurement of the progressing lesions will be documented * Patients should have completed any major surgery \>= 4 weeks prior to registration and must have completed any minor surgery \>= 2 weeks prior to registration; patients must have fully recovered from the procedure * The following are examples of procedures considered to be minor: port placement, laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and dental extraction procedures * Insertion of a vascular access device, thoracentesis, paracentesis, and endoscopic ultrasonographic procedures are not considered to be major or minor surgeries * No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents * No clinical evidence of central nervous system (CNS) metastases (including carcinomatous meningitis) at baseline, with the exception of those patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) had no requirement for steroids or enzyme-inducing anticonvulsants within 6 months prior to registration * No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration * No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 28 days prior to registration including, but not limited to: * Active peptic ulcer * Known endoluminal metastatic lesion(s) with history of bleeding * Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation * No history of serious (i.e., requiring active medical therapy with medication or medical device under the supervision of a physician) non-healing wound, ulcer, trauma, or bone fracture within 28 days prior to study entry * Patients with a history of hypertension must have blood pressure that is adequately controlled on antihypertensives; (\< 140/90 mm Hg) * No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration * No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, myocardial infarction (MI), or unstable angina or angina requiring surgical or medical intervention in 6 months prior to registration; patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible; patients who have experienced a deep venous thrombosis or pulmonary embolus within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 6 weeks prior to enrollment of this study * Patients on therapeutic anticoagulation with low molecular weight heparins, fondaparinux, rivaroxaban or warfarin are eligible, provided that they are on a stable dose of anticoagulants; patients who are currently receiving antiplatelet therapy of prasugrel or clopidogrel or antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or low doses of acetylsalicylic acid (up to 100 mg daily) are also eligible * No ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of corrected QT (QTc) interval to \> 480 msec * No evidence of active bleeding, bleeding diathesis, or hemoptysis (\>= 1/2 teaspoon of red blood) within 8 weeks prior to registration * No currently unstable angina and/or uncontrolled cardiac arrhythmias * Patients with symptomatic peripheral vascular disease are ineligible * Ejection fraction on echocardiogram (Echo) or multi gated acquisition scan (MUGA) \> 50% * Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment * Women must not be pregnant or nursing; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 72 hours prior to registration; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \>= 12 consecutive months; or women on hormone replacement therapy \[HRT\] with documented serum follicle stimulating hormone \[FSH\] level \> 35 mIU/mL) * Age \>= 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Granulocytes \>= 1,500/mcL * Platelets \>= 100,000/mcL * International normalized ratio (INR) =\< 1.2 X upper limit of normal (ULN); only required for patients receiving anticoagulant therapy; patients are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation * QTc =\< 480 msecs * Thyroid stimulating hormone (TSH) within normal limits (WNL); medications for thyroid dysfunction are allowed as long as TSH is normal at registration; in patients with abnormal TSH, if the free thyroxine (free T4) and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible * Bilirubin =\< 1.5 x ULN * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \& alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN; concomitant elevations in bilirubin and AST/ALT above 1.0 X ULN are NOT permitted; also, if liver metastases are present, AST \& ALT =\< 5 x ULN is allowed * Serum creatinine =\< 1.5 x ULN * Urine protein to creatinine ratio \< 1, or, 24-hour urine protein \< 1 g; if urine protein to creatinine (UPC) \>= 1, then a 24-hour urine protein must be assessed; patients must have a 24-hour urine protein value \< 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable

Primary outcome measure(s)

  • Progression-free Survival (PFS) — From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years
    PFS will be measured from date of patient entry until documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.

Trial sites (423)

FacilityCityRegionStatus
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Mayo Clinic in Arizona Scottsdale Arizona
Kaiser Permanente-Anaheim Anaheim California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Fontana Fontana California
Kaiser Permanente South Bay Harbor City California
Kaiser Permanente-Irvine Irvine California
Kaiser Permanente Los Angeles Medical Center Los Angeles California
Los Angeles General Medical Center Los Angeles California
USC / Norris Comprehensive Cancer Center Los Angeles California
Kaiser Permanente West Los Angeles Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Palo Alto Medical Foundation Health Care Palo Alto California
Stanford Cancer Institute Palo Alto Palo Alto California
Kaiser Permanente - Panorama City Panorama City California
Kaiser Permanente-Riverside Riverside California
Kaiser Permanente-Rio San Diego San Diego California
Kaiser Permanente-San Diego Zion San Diego California
UCSF Medical Center-Mount Zion San Francisco California
UCSF Medical Center-Mission Bay San Francisco California
Kaiser Permanente-San Marcos San Marcos California
Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
Kaiser Permanente-Woodland Hills Woodland Hills California
The Medical Center of Aurora Aurora Colorado
Boulder Community Foothills Hospital Boulder Colorado
Rocky Mountain Cancer Centers-Boulder Boulder Colorado
Penrose-Saint Francis Healthcare Colorado Springs Colorado
Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
AdventHealth Porter Denver Colorado
Colorado Blood Cancer Institute Denver Colorado
Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
Rocky Mountain Cancer Centers-Midtown Denver Colorado
Saint Joseph Hospital - Cancer Centers of Colorado Denver Colorado
Rocky Mountain Cancer Centers-Rose Denver Colorado
Rose Medical Center Denver Colorado

+ 383 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01841736 on ClinicalTrials.gov ↗ ← All trials in Mexico