Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01841736
First received: April 24, 2013
Last updated: September 12, 2014
Last verified: April 2014
  Purpose

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with progressive carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Condition Intervention Phase
Metastatic Gastrointestinal Carcinoid Tumor
Pulmonary Carcinoid Tumor
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Neuroendocrine Carcinoma of the Skin
Regional Gastrointestinal Carcinoid Tumor
Stage III Neuroendocrine Carcinoma of the Skin
Stage IV Neuroendocrine Carcinoma of the Skin
Thyroid Gland Medullary Carcinoma
Drug: pazopanib hydrochloride
Other: placebo
Other: quality-of-life assessment
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase II Trial of Pazopanib (NSC # 737754) Versus Placebo in Patients With Progressive Carcinoid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    PFS will be estimated within treatment arm using the Kaplan-Meier method.


Secondary Outcome Measures:
  • Objective response rate (ORR), defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The exact binomial confidence interval will be used to estimate ORR.

  • Overall survival (OS) [ Time Frame: From randomization until death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    OS will be estimated by the Kaplan-Meier method within each treatment arm.

  • Duration of response (DR) for the subset of patients with a confirmed CR or PR [ Time Frame: From first documented evidence of CR or PR until first documented disease progression or death from any cause, assessed up to 5 years ] [ Designated as safety issue: No ]
    DR will be summarized descriptively using Kaplan-Meier medians and quartiles.

  • Time to treatment failure [ Time Frame: From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Time to second progression for patients who crossover from placebo to active therapy [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: June 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Given PO
Other Names:
  • GW786034B
  • Votrient
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I.
Other: placebo
Given PO
Other Name: PLCB
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (measureable 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 brochi 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)
  • 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 4 weeks prior to registration, and any treatment-related toxicities must have improved to =< grade 1
  • 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
  • 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 mmHg)
  • 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, unstable angina or angina requiring surgical or medical intervention in 6 months prior to registration, or myocardial infarction (MI); 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, 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 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)
  • 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
  • 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 (UPC) ratio < 1, or, 24-hour urine protein < 1g; if 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841736

  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Edward M. Wolin    310-423-8965      
Principal Investigator: Edward M. Wolin         
University of Southern California/Norris Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Syma Iqbal    323-865-0451      
Principal Investigator: Syma Iqbal         
UCSF-Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Emily K. Bergsland    877-827-3222      
Principal Investigator: Emily K. Bergsland         
United States, Colorado
Front Range Cancer Specialists Withdrawn
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital Active, not recruiting
Fort Collins, Colorado, United States, 80524
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Jonathan R. Strosberg    800-456-7121    canceranswers@moffitt.org   
Principal Investigator: Jonathan R. Strosberg         
United States, Georgia
John B Amos Cancer Center Recruiting
Columbus, Georgia, United States, 31904
Contact: Andrew W. Pippas    706-660-6404      
Principal Investigator: Andrew W. Pippas         
United States, Hawaii
Pali Momi Medical Center Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Oncare Hawaii Inc-Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Oncare Hawaii Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
OnCare Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817-3169
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
Castle Medical Center Terminated
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey L. Berenberg    808-586-2979      
Principal Investigator: Jeffrey L. Berenberg         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Al B. Benson    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Al B. Benson         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Manish R. Sharma    773-834-7424      
Principal Investigator: Manish R. Sharma         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Janelle M. Meyer    708-226-4357      
Principal Investigator: Janelle M. Meyer         
United States, Indiana
Indiana University Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Paul R. Helft    317-274-2552      
Principal Investigator: Paul R. Helft         
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Robin T. Zon    574-234-5123      
Principal Investigator: Robin T. Zon         
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin T. Zon    574-234-5123      
Principal Investigator: Robin T. Zon         
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Nancy Sharma    800-237-1225      
Principal Investigator: Nancy Sharma         
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Jyotsna Fuloria    888-562-4763      
Principal Investigator: Jyotsna Fuloria         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Tareq Al Baghdadi    734-712-4673      
Principal Investigator: Tareq Al Baghdadi         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Tareq Al Baghdadi    734-712-4673      
Principal Investigator: Tareq Al Baghdadi         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
United States, Minnesota
Essentia Health Duluth Clinic CCOP Recruiting
Duluth, Minnesota, United States, 55805
Contact: Bret E. Friday    888-203-7267      
Principal Investigator: Bret E. Friday         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
United States, Missouri
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Saint Louis Cancer and Breast Institute-South City Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Jay W. Carlson    800-821-7532    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Benjamin R. Tan    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Benjamin R. Tan         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: J. M. Pipas    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: J. M. Pipas         
United States, New York
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Steven K. Libutti    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Steven K. Libutti         
Montefiore Medical Center-Einstein Campus Recruiting
Bronx, New York, United States, 10461
Contact: Steven K. Libutti    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Steven K. Libutti         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan W. Friedberg    585-275-5830      
Principal Investigator: Jonathan W. Friedberg         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stephen A. Bernard    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stephen A. Bernard         
Margaret R Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford    828-696-4716      
Principal Investigator: James E. Radford         
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson    252-559-2200      
Principal Investigator: Peter R. Watson         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jennifer R. Eads    800-641-2422      
Principal Investigator: Jennifer R. Eads         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Manisha H. Shah    866-627-7616    osu@emergingmed.com   
Principal Investigator: Manisha H. Shah         
Saint Vincent Mercy Medical Center Terminated
Toledo, Ohio, United States, 43608
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Carla Kurkjian    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Carla Kurkjian         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Carla Kurkjian    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Carla Kurkjian         
United States, Oregon
Providence Milwaukie Hospital Terminated
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Providence Willamette Falls Medical Center Recruiting
Oregon City, Oregon, United States, 97045
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
United States, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Darius C. Desai    610-954-3582    infolink@slhn.org   
Principal Investigator: Darius C. Desai         
United States, South Carolina
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute/Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Jeffrey K. Giguere    864-241-6251      
Principal Investigator: Jeffrey K. Giguere         
United States, Wisconsin
Sacred Heart Hospital Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Rezwan Islam    715-393-1400      
Principal Investigator: Rezwan Islam         
Marshfield Clinic Cancer Center at Sacred Heart Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Rezwan Islam    715-393-1400      
Principal Investigator: Rezwan Islam         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Noelle K. LoConte    877-405-6866      
Principal Investigator: Noelle K. LoConte         
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Rezwan Islam    715-393-1400      
Principal Investigator: Rezwan Islam         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: James P. Thomas    414-805-4380    osu@emergingmed.com   
Principal Investigator: James P. Thomas         
Marshfield Clinic-Rice Lake Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Rezwan Islam    715-393-1400      
Principal Investigator: Rezwan Islam         
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Cynthia M. Card    403-521-3433      
Principal Investigator: Cynthia M. Card         
Canada, British Columbia
BCCA-Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Hagen F. Kennecke    888-939-3333      
Principal Investigator: Hagen F. Kennecke         
Canada, New Brunswick
The Vitalite Health Network - Dr Leon Richard Oncology Centre Recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Contact: Nicholas G. Finn    506-862-4005      
Principal Investigator: Nicholas G. Finn         
Canada, Nova Scotia
QEII Health Sciences Centre/Capital District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 1V8
Contact: Daniel Rayson    902-473-6000      
Principal Investigator: Daniel Rayson         
Canada, Ontario
Ottawa Health Research Institute-General Division Recruiting
Ottawa, Ontario, Canada, K1H 1C4
Contact: Timothy R. Asmis    613-761-4395    info@ohri.ca   
Principal Investigator: Timothy R. Asmis         
University Health Network-Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Monika K. Krzyzanowska    416-946-4501    clinical.trials@uhn.on.ca   
Principal Investigator: Monika K. Krzyzanowska         
Sponsors and Collaborators
Investigators
Principal Investigator: Emily Bergsland Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01841736     History of Changes
Other Study ID Numbers: NCI-2013-00831, NCI-2013-00831, ALLIANCE A021202, CALGB-A021202, A021202, A021202, U10CA031946, U10CA180821
Study First Received: April 24, 2013
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Carcinoma, Neuroendocrine
Skin Neoplasms
Carcinoma
Neoplasms
Carcinoma, Merkel Cell
Carcinoma, Medullary
Thyroid Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Skin Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms, Ductal, Lobular, and Medullary
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014