Clinical Trial to Assess the Importance of Nephrectomy - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	Pfizer
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00930033

Purpose

The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context

Condition	Intervention	Phase
Metastatic Renal Cell Carcinoma	Procedure: Nephrectomy Other: Sunitinib alone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib

Resource links provided by NLM:

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

The primary endpoint is overall survival. [ Time Frame: starting at 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective Response (complete or partial) is evaluated according to RECIST criteria [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
Clinical benefit (complete response, partial or stable for at least 12 weeks). [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
Progression-Free Survival [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
Tolerance is evaluated according to NCI-CTC v3. [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	576
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Nephrectomy + sunitinib	Procedure: Nephrectomy Current surgery
B: Experimental Sunitinib alone	Other: Sunitinib alone Sunitinib alone without nephrectomy

Detailed Description:

The 2 previous studies on the impact of nephrectomy (EORTC, SWOG) in metastatic renal cell carcinoma have justified recommendation to initial nephrectomy for patients presenting with metastatic renal cell carcinoma. But these studies were performed at the time of immunotherapy.

The objective is Evaluation of the importance of nephrectomy in patients with metastatic renal cell carcinoma treated with sunitinib (AA) Arm A : Nephrectomy followed by Sunitinib Arm B : Sunitinib alone Sunitinib will be administrated orally daily for 4 weeks followed by a 2 week rest( schedule 4/2), 6 weeks are considered as a cycle The starting dose will be 50 mg daily with provision for dose reduction based on tolerability Patient will be treated until disease progression or unacceptable toxicity occurrence or withdraw.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 year
ECOG Performance Status 0 - 1
Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma alone or preponderant (> 50%)
Documented metastatic disease
Absence of prior systemic treatment for kidney cancer including AA
Tumour accessible to nephrectomy (partial or total), according to the patient's surgical urologist. Patients presenting with an inferior vena cava thrombosis can be included.
Patients for which the indication of Sutent is considered according to the recommendations rules given by national health authorities of participating countries. The prescription of Sutent in the circumstances of the study is considered as a standard treatment.
Platelets > or = 100 x 109/L, hemoglobin > or = 9 g/dl, neutrophils > or =1.5 x 109/L;
Bilirubin < or = 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT) < or = 2.5 times the upper normal limit (UNL) or < or = 5 times UNL for patients with liver metastases
Patients of child bearing age should use contraceptive methods
Patient able to follow the procedures outlined in the protocol as far as the planning of visits and exams are concerned.
Life expectancy ≥ 3 months
Affiliated with social security health insurance
Written informed consent

Exclusion Criteria:

Prior systemic treatment for kidney cancer (including Anti angiogenic)
Pregnant or breast feeding women
Non stabilised coronaropathy or episode of myocardial infarction or severe or unstable angora within the last 6 months as well as severe diabetes with severe peripheral arteriopathy or deep phlebitis or arterial thrombosis within the last 3 months
Anticoagulants with curative intent
Medical, general or psychiatrics difficulties non compatibles with the study
Brain metastases
Prior radiotherapy for kidney cancer
Previous history of gastric disease or of the small intestine, syndrome of insufficient absorption compromising the absorption of Sunitinib
Experimental treatment within the 28 days preceding inclusion
Other cancer within the previous 5 years (except for insitu skin carcinoma and treated localised prostate cancer with undetectable PSA)
Medical disease, acute or chronic psychiatric problems or biologic perturbations which could aggravate during the study or the administration of Sunitinib or which could interfere with the interpretation of results or for whatever other reason which could appear according to the appreciation of the investigator
Sunitinib hypersensibility

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930033

Contacts

Contact: Arnaud Mejean, MD, PhD	+33(0)1 44 49 53 36	arnaud.mejean@nck.aphp.fr
Contact: Raphael Serreau, MD, PhD	+33(0)1 58 41 11 80	raphael.serreau@cch.aphp.fr

Locations

France
Hopital Necker	Recruiting
Paris, France, 75015
Principal Investigator: Arnaud Mejean, MD, PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Pfizer

Investigators

Principal Investigator:

Arnaud Mejean, MD PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department Clinical Research of Developpement ( Zakia Idir )
Study ID Numbers:	P070144
Study First Received:	June 29, 2009
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00930033 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Nephrectomy,
metastatic renal cell carcinoma,
sunitinib

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Urologic Diseases
Kidney Neoplasms
Sunitinib
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010