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Trial record 20 of 75 for:    "Carotid body tumor"

Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable Metastatic Pheochromocytomas and Paragangliomas

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ClinicalTrials.gov Identifier: NCT02302833
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if cabozantinib can help to control advanced or metastatic pheochromocytoma or paraganglioma. The safety of this drug will also be studied.

This is an investigational study. Cabozantinib is FDA-approved and commercially available for the treatment of metastatic medullary thyroid cancer. It is investigational to give cabozantinib to patients with pheochromocytoma or paraganglioma. The study doctor can explain how the study drug is designed to work.

Up to 22 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Cabozantinib Behavioral: Questionnaire Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable Metastatic Pheochromocytomas and Paragangliomas
Actual Study Start Date : February 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: Cabozantinib
Participants take Cabozantinib by mouth at a dose of 60 mg once daily. Questionnaire completion regarding symptoms completed at baseline, 4 days before starting Cabozantinib, and weekly while taking the drug.
Drug: Cabozantinib
60 mg by mouth once daily.
Other Names:
  • XL-184
  • XL184

Behavioral: Questionnaire
Questionnaire completion regarding symptoms completed at baseline, 4 days before starting Cabozantinib, and weekly while taking the drug.
Other Name: Survey




Primary Outcome Measures :
  1. Overall Response Rate of Cabozantinib in Participants with Malignant Pheochromocytomas and Paragangliomas [ Time Frame: 8 weeks ]
    Primary endpoint is to estimate best overall response rate by RECIST 1.1 in participants with measurable disease determined by CT/MRI. Tumor response assessed at a frequency of 8 weeks. In participants with bone metastases, an FDG-PET scan obtained every 8 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Histological confirmation of PH/PG
  3. Locally advanced or metastatic disease not amenable to surgery
  4. Patients enrolled in the main branch should have measurable disease. Patients with a predominance of bone disease who have small, non-measurable or small measurable lesions other than bone, may be included per the Principal Investigator's discretion, in the exploratory branch of the study for patients with bone metastases only.
  5. Progressive disease per RECIST 1.1 as determined by the investigator within the 12 months preceding study enrollment
  6. Assessment of all known disease sites, eg, by CT scan, MRI, bone scan as appropriate, and/or FDG-PET scan within 28 days before the first dose of cabozantinib
  7. Eastern Cooperative Oncology Group (ECOG) performance status <=2
  8. Life expectancy of at least 3 months
  9. Organ and marrow function and laboratory values as follows within 4 days prior to the first dose of cabozantinib: a. Absolute neutrophil count (ANC) >/= 1500/mm^3 without colony stimulating factor support, b. Platelets >/= 100,000/mm^3, c. Hemoglobin >/= 9 g/dL d. Bilirubin </= 1.5 x the upper limit of normal (ULN) (For subjects with known Gilbert's disease, bilirubin </= 3.0 mg/dL), e. Serum albumin >/= 2.8 g/dl, f. Serum creatinine </= 1.5 x ULN or creatinine clearance (CrCl) >/= 50 mL/min (For creatinine clearance estimation, the Cockcroft and Gault equation should be used: Male: CrCl (mL/min)=(140 - age)×weight (kg) / (serum creatinine × 72); Female: Multiply above result by 0.85, g. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)</= 3.0 x ULN, h.Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis, i.Urine protein/creatinine ratio (UPCR)</=1, j.Serum phosphorus, calcium, potassium >/= lower limit of normal (LLN) and magnesium >/= 1.2 mg/dL.
  10. Capable of understanding and complying with the protocol requirements and has signed the informed consent document
  11. Sexually active patients (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s).
  12. Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea >/= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.

Exclusion Criteria:

  1. Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/ mitomycin C within 6 weeks before the first dose of study treatment.
  2. Prior treatment with cabozantinib
  3. Radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  4. Received radionuclide treatment (i.e. I-131 meta-iodo- benzyl guanidine) within 6 months of the first dose of study treatment
  5. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment.
  6. Receipt of any other type of investigational agent within 28 days before the first dose of study treatment.
  7. The subject has not recovered to baseline or CTCAE </= Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.
  8. Prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >/= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment.
  9. The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel). Low dose aspirin (</= 81 mg/day), low-dose warfarin (</= 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted.
  10. The subject requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's Wort).
  11. The subject has experienced any of the following: a. clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment, b. hemoptysis of >/= 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment, c. any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  12. Radiographic evidence of cavitating pulmonary lesion(s)
  13. Tumor invading or encasing any major blood vessels
  14. Evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib.
  15. Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: a. Cardiovascular disorders including: i. Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening, ii. Concurrent uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment, iii. Any history of congenital long QT syndrome, or iv. Any of the following within 6 months before the first dose of study treatment: unstable angina pectoris, clinically-significant cardiac arrhythmias, stroke (including TIA, or other ischemic event), myocardial infarction, or thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study); CONTINUED BELOW
  16. b. Gastrointestinal disorders, particularly those associated with a high risk of perforation or fistula formation, including: i. Any of the following within 28 days before the first dose of study treatment: intra-abdominal tumor/metastases invading GI mucosa, active peptic ulcer disease (patients must be completely recovered), inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis (patient must be completely recovered from these conditions), malabsorption syndrome; ii. Any of the following within 6 months before the first dose of study treatment: abdominal fistula, gastrointestinal perforation, bowel obstruction or gastric outlet obstruction, or intra-abdominal abscess. (Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 6 months before the first dose of study treatment.); CONTINUED BELOW
  17. c. Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy, or CONTINUED BELOW
  18. d. Other clinically significant disorders such as: i. active infection requiring systemic treatment within 28 days before the first dose of study treatment, ii. serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment, iii. history of organ transplant, iv. concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment, or v. Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
  19. Unable to swallow tablets
  20. A corrected QT interval calculated by the Fridericia formula (QTcF) >500 ms within 28 days before first dose of study treatment . Three ECGs must be performed. If the average of these three consecutive results for QTcF is </= 500 msec, the subject meets eligibility in this regard.
  21. Pregnant or breastfeeding.
  22. A previously identified allergy or hypersensitivity to components of the study treatment formulation.
  23. Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
  24. Evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment except for cured nonmelanoma skin cancer or cured in situ cervical carcinoma
  25. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the patient inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302833


Contacts
Contact: Camilo Jimenez, MD 713-792-2841

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Exelixis
Investigators
Principal Investigator: Camilo Jimenez, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02302833     History of Changes
Other Study ID Numbers: 2014-0081
NCI-2014-02607 ( Registry Identifier: NCI CTRP )
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Neuroendocrine tumors
Pheochromocytomas
Paragangliomas
Unresectable
Metastatic
Cabozantinib
XL-184
XL184
Questionnaire
Survey

Additional relevant MeSH terms:
Neuroendocrine Tumors
Pheochromocytoma
Paraganglioma
Carotid Body Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Paraganglioma, Extra-Adrenal