Bevacizumab, Interleukin-2 and Interferon-alpha in metastathic renal cell carcinoma - mRCC

Department of Oncology, Aarhus University Hospital0 sites118 target enrollmentMay 28, 2009

DrugsAvastin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Department of Oncology, Aarhus University Hospital
Enrollment: 118
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 28, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Department of Oncology, Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

•1\.Signed written informed consent obtained prior to any study specific screening procedures.
•2\.Patient must be willing and able to comply with the protocol.
•3\.Age ? 18\.
•4\.Histologic og cytologic biopsy proven locally advanced or metastatic renal cell carcinoma, considered non\-candidates for curative surgery. Nephrectomy is not mandatory.
•5\.Patient with renal cell carcinoma (RCC) with a clear\-cell histologic component confirmed by local pathology review. (Patient with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumours, Bellini tumours and transitional cell carcinoma are not allowed.)
•6\.If metastatic disease is diagnosed more than two years from the date of the initial diagnosis of RCC, histological or cytological confirmation of renal cell carcinoma (clear cell type) origin of the metastatic lesion(s) is mandatory.
•7\.Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
•8\.Fertile women of childbearing potential (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilisation).
•9\.Memorial\-Sloan\-Kettering\-Cancer\-Centre favourable\- and intermediate prognostic group.
•10\.Measurable or non\-measurable disease (as per RECIST criteria)

Exclusion Criteria

•1\.Prior systemic treatment for metastatic RCC disease (including neo\-adjuvant therapy).
•2\.Major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to randomization.
•3\.Serious non\-healing wound, ulcer or bone fracture.
•4\.Evidence of current central nervous system (CNS) metastases or spinal cord compression. Patient must undergo an MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to randomization.
•5\.Seizure(s) not controlled with standard medical therapy.
•6\.Dipstick urine test of protein \= 2\+.
•7\.Other malignancies within 5 years prior to randomization (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix).
•8\.Evidence of bleeding diathesis or coagulopathy.
•9\.Ongoing or recent (within 10 days prior to study treatment start) need for full therapeutic dose of oral anticoagulants or chronic daily treatment with aspirin. Low molecular weight heparin are allowed
•10\.Uncontrolled hypertension (? 160 mm Hg systolic and/or ? 100 mm Hg diastolic) while receiving chronic medication.