A Study of Axitinib in Advanced Carcinoid Tumors

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Brief Title

A Study of Axitinib in Advanced Carcinoid Tumors

Official Title

A Phase II Study of Axitinib in Advanced Carcinoid Tumors

Brief Summary

      The main purpose of this study is to see whether Axitinib will help prolong the time that the
      patient's carcinoid tumors remain stable, and to examine their treatment response through
      testing. Researchers also want to find out if Axitinib is safe and tolerable.

Detailed Description

      This is a bi-institutional, prospective phase II, open-label study. The target population is
      comprised of adult patients with histologically confirmed unresectable or metastatic
      carcinoid tumors. Carcinoid tumors are defined as well to moderately differentiated
      neuroendocrine tumors of the digestive tract and lungs. Patients with metastatic carcinoid
      tumors of unknown primary as well as rare primaries (renal, ovarian, thymic, hepatic) will
      also be eligible. Patients will be drawn from two institutions Moffitt Cancer Center (MCC)
      and The University of California, San Francisco (UCSF).

Study Phase

Phase 2

Study Type


Primary Outcome

Rate of Progression Free Survival (PFS)

Secondary Outcome

 Tumor Response Rate


Carcinoid Tumor



Study Arms / Comparison Groups

 Axitinib Administration
Description:  The investigational drug used in this study is axitinib, and is available as tablets.
You will take the tablet orally with food. Doses should be taken around 12 hours apart continuously, without scheduled breaks. If you vomit anytime after taking a dose do not take another tablet to "make up the dose" but instead continue taking your next dose as planned.
Any missed dose may be taken late (up to 3 hours before the next scheduled dose); otherwise it should be skipped. If doses are missed or vomited, please keep track of this and report at your next visit.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

October 25, 2011

Completion Date

February 13, 2018

Primary Completion Date

January 11, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Locally unresectable or metastatic well-and moderately-differentiated (low- or
             intermediate- grade) neuroendocrine tumors of the aerodigestive tract (e.g. foregut,
             midgut, and hindgut) and unknown primary site as well as rare primary sites (renal,
             ovarian, thymic, hepatic); Otherwise known as typical or atypical carcinoid tumors

          -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria

          -  Functional or nonfunctional tumors allowed

          -  Evidence of progressive disease within 12 months of study entry

          -  Adequate hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN)mg/dl;
             aspartic transaminase (AST) ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases)

          -  Adequate renal function: serum creatinine ≤ 1.5 x ULN

          -  Adequate bone marrow function: absolute neutrophil count ≥ 1,500/mm³; platelets

          -  Prothrombin time (PT) and activated partial thromboplastin time (aPTT) levels ≤1.5 x
             ULN (unless patients receiving coumadin anticoagulation in which case a stable
             international normalization ration (INR) of 2-3 is required).

          -  Urine protein <2+proteinuria (or <2 g proteinuria /24 hr)

          -  Prior somatostatin-analog therapy required in patients with midgut carcinoid tumors

          -  Minimum 4 weeks since completion of prior treatment (investigational or other). Prior
             treatment with chemotherapy, radiotherapy, hepatic artery embolization, surgery or
             other therapeutic agents is allowed.

          -  Treatment related toxicity should have returned to baseline and/or ≤grade 1 prior to
             study treatment.

          -  Prior or concurrent therapy with somatostatin analogs is permitted for the control of
             hormone-mediated symptoms, provided patient has been on a stable dose for at least 2
             months and progressive disease on somatostatin analogs (SSTa) has been documented

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Women of childbearing potential must have a negative serum pregnancy test within 14
             days prior to treatment.

          -  Ability to sign informed consent

          -  Willingness and ability to comply with scheduled visits, laboratory tests and other
             study procedures

        Exclusion Criteria:

          -  Poorly differentiated, high-grade (e.g. small cell or large cell) neuroendocrine
             carcinomas are excluded.

          -  Pancreatic neuroendocrine tumors (NETs), paragangliomas, pheochromocytomas and
             medullary thyroid cancers are excluded.

          -  Adenocarcinoid tumors and goblet cell carcinoid tumors are excluded.

          -  Prior antiangiogenic therapy with a dedicated vascular endothelial growth factor
             (VEGF) pathway inhibitor

          -  Clinically apparent central nervous system metastases

          -  Any of the following within 12 months prior to study: myocardial infarction,
             uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive
             heart failure, cerebrovascular accident, or transient ischemic attack

          -  Deep venous thrombosis or pulmonary embolism within 6 months of study

          -  Major surgery 4 weeks prior to enrollment

          -  Inability to take oral medication or prior surgical procedures affecting absorption
             (including total gastric resection)

          -  Active gastrointestinal bleeding, if transfusion dependent

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within the past 28 days

          -  History of pulmonary hemorrhage or evidence of significant hemoptysis

          -  History of serious non-healing wound, ulcer, or bone fracture within the past 28 days

          -  Pre-existing thyroid abnormality allowed provided thyroid function can be controlled
             with medication.

          -  Current use or anticipated need for treatment with drugs that are known potent CYP3A4
             inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole,
             erythromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, etc.)

          -  Current use or anticipated need for treatment with drugs that are known inducers of
             CYP3AR or CYP1A2 (i.e carbamazepine, dexamethasone, omeprazole, phenobarbital,
             phenytoin, rifampin, St. John's Wart, etc.)

          -  Uncontrolled serious medical or psychiatric illness. Patients with a "currently
             active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of
             the cervix, resected incidental prostate cancer (staged pathological tumor-2 (pT2)
             with Gleason Score ≤ 6 and postoperative prostatic specific antigen (PSA) < 0.5
             ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not
             considered to have a "currently active" malignancy if they have completed therapy and
             are free of disease for ≥3 years.

          -  Pregnant or lactating women, or adults of reproductive potential who are not using
             effective birth-control methods.

          -  Prior antitumor therapy within 4 weeks of enrollment (with exception of somatostatin

          -  Liver-directed therapy within 2 months of enrollment. Prior treatment with
             radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial
             embolization (with or without chemotherapy) or cryotherapy/ablation is allowed if
             these therapies did not affect the areas of measurable disease being used for this
             protocol or if progressive disease can be documented in the previously treated area.

          -  Recent infection requiring systemic anti-infective treatment that was completed ≤14
             days prior to enrollment (with the exception of uncomplicated urinary tract infection
             or upper respiratory tract infection)

          -  Uncontrolled hypertension (blood-pressure >140/90). Patient with baseline hypertension
             may be eligible after initiation of antihypertensive therapy.




18 Years - N/A

Accepts Healthy Volunteers



Jonathan Strosberg, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

H. Lee Moffitt Cancer Center and Research Institute


 National Comprehensive Cancer Network

Study Sponsor

Jonathan Strosberg, M.D., Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute

Verification Date

August 2018