Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)
NCT02597322
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Patients must sign IRB/EC-approved informed consent.
- Age ≥ 18
- Histologically proven clear cell RCC (obtained by CT or US guided biopsy)
- cT2a N0NxM0 Renal tumor according to 2009 TNM classification (tumor Ø> 7cm; ≤ 10 cm)
- No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
- Normal renal function (MDRD creatinin clearance ≥ 60 ml/min)
- Patients must have adequate organ function defined as: Platelets ≥ 150 x 109/L, hemoglobin > 9 g/dl, absolute neutrophil count (ANC) >1.5 x 109/L; Bilirubin < 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal; Total cholesterol ≤ 9.1 mmol/l and triglyceride level ≤ 4.5 mmol/l
- Urinary protein <2+ by urine dipstick.
- Patients with reproductive potential must use medically acceptable contraceptive method.
- Beneficiary of a social coverage (except AME)
- Patients with < 50 % clear cell histology
- Evidence of locally advanced disease: cT stage≥T2b, N Stage≥1 or metastatic disease
(M1)
- Patients must not be pregnant or lactating.
- Patients must not have uncompensated coronary artery disease or an history of
myocardial infarction or severe or unstable angina within the past six months or
severe diabetes mellitus with severe arterial peripheral disease or deep venous or
arterial thrombosis or embolism with the past 3 months. Patients must not need
curative anticoagulants.
- Patients must not have any medical/systemic or psychiatric disorder incompatible with
the study.
- Patients must not have a history of significant gastric or small bowel resection,
malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract
that may compromise the absorption of Axitinib or an unavailability of the oral route.
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Descriptive Information | ||||
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Brief Title ICMJE | Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN) | |||
Official Title ICMJE | An Open-label, Non-randomized, Multicenter, Two Stage Designed Phase II Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN) | |||
Brief Summary | Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in phase II study in cytokine-refractory metastatic renal-cell cancer patients. Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with large organ confined tumors to benefit from NSS. The Objective is to determine the efficacy of Axitinib administered prior to surgery in patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for shifting from a radical nephrectomy indication to a nephron sparing procedure. | |||
Detailed Description | Radical nephrectomy (RN) is the current standard of care for large organ confined renal tumors. Experience and surgical technical improvements have allowed the feasibility of Nephron Sparing Surgery (NSS) in tumors larger than 4 cm and up to 7cm. Very limited data exist regarding the feasibility and safety of NSS in tumors larger than 7cm. It has been demonstrated that NSS compared to RN offers similar oncological outcome while better preserving renal function and thus improving overall survival. The purpose of this study is to test the possibility of offering patients with large organ confined renal tumors, candidates for radical nephrectomy according to current guidelines the benefit of partial nephrectomy thanks to axitinib neo-adjuvant treatment. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | cT2a N0NxM0 Renal Tumor | |||
Intervention ICMJE | Drug: AXITINIB
Axitinib is an oral, potent, and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3 It will be supplied as 1 mg and 5 mg film coated tablets for oral administration in light protecting bottles of 60 tablets. Other Name: AG013736 | |||
Study Arms ICMJE | Experimental: AXITINIB
Intervention: Drug: AXITINIB | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 21 | |||
Original Estimated Enrollment ICMJE | 55 | |||
Actual Study Completion Date ICMJE | June 2017 | |||
Actual Primary Completion Date | November 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02597322 | |||
Other Study ID Numbers ICMJE | P110209 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Assistance Publique - Hôpitaux de Paris | |||
Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Assistance Publique - Hôpitaux de Paris | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |