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Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN) (AXIPAN)

Primary Purpose

cT2a N0NxM0 Renal Tumor

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

AXITINIB

About this trial

This is an interventional treatment trial for cT2a N0NxM0 Renal Tumor focused on measuring Axitinib, T2a Renal tumor, organ confined tumors, nephron sparing surgery, nephron sparing procedure, radical nephrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

Bicêtre Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXITINIB

Arm Description

Outcomes

Primary Outcome Measures

The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm

Secondary Outcome Measures

Response rate according to RECIST criteria

Number of participants with treatment-related serious adverse events and their grades according to CTCAE V4.0.

Renal function assessed by serum creatinin

Renal function assessed by calculated glomerular filtration rate (GFR) according to MDRD formula

Renal function assessed by renal scintigraphy

Full Information

NCT ID

NCT02597322

First Posted

June 8, 2015

Last Updated

July 24, 2017

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02597322

Brief Title

Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)

Acronym

AXIPAN

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

cT2a N0NxM0 Renal Tumor

Keywords

Axitinib, T2a Renal tumor, organ confined tumors, nephron sparing surgery, nephron sparing procedure, radical nephrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AXITINIB

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AXITINIB

Other Intervention Name(s)

AG013736

Intervention Description

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.

Primary Outcome Measure Information:

Title

The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm

Time Frame

At 6 months after beginning of the treatment

Secondary Outcome Measure Information:

Title

Response rate according to RECIST criteria

Time Frame

At 30 months after beginning of the treatment

Title

Number of participants with treatment-related serious adverse events and their grades according to CTCAE V4.0.

Time Frame

At 30 months after beginning of the treatment

Title

Renal function assessed by serum creatinin

Time Frame

At baseline and at 30 months after beginning of the treatment

Title

Renal function assessed by calculated glomerular filtration rate (GFR) according to MDRD formula

Time Frame

At baseline and at 30 months after beginning of the treatment

Title

Renal function assessed by renal scintigraphy

Time Frame

At baseline and at 30 months after beginning of the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Jacques Patard, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bicêtre Hospital

City

Le Kremlin Bicêtre

ZIP/Postal Code

94275

Country

France

12. IPD Sharing Statement

Learn more about this trial

Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)

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