Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases

NCT01444807 | Unknown Phase 2

• 1 other identifier: GP1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 14

Brief Summary

Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy

Conditions

Metastatic Renal Cell Carcinoma

Keywords

sorafenib; metastatic renal cell carcinoma; metastasectomy

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

  Efficacy of Sorafenib compared with BSC, in RCC patients that have undergone radical resection of recurrent metastatic disease, after prior nephrectomy. The primary efficacy endpoint is Recurrence Free Survival (RFS),

  December 2011 - December 2014 (3 years)

Secondary Outcomes (3)

• Overall Survival

  December 2011 - December 2014 (3 years)

• Safety Profile

  December 2011 - December 2014 (3 years)

• Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm.

  December 2011 - December 2014 (3 years)

Study Arms (2)

Sorafenib

EXPERIMENTAL

Active Arm

Drug: sorafenib

Best Supportive Care

NO INTERVENTION

Comparator

Interventions

sorafenib DRUG

sorafenib 400 mg bid

Also known as: Nexavar (Bayer Health Care - Leverkusen - Germany)

Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with cytological or histological diagnosis of Renal Cell Carcinoma (RCC)
• Absence of residual lesions following surgical removal of metastatic disease. Assessment must be performed by CT-scan or MRI
• Histologically proven disease free margins of resected surgical specimen
• No more than three months from radical resection on metastases.
• ECOG Performance Status of 0 or 2
• Life expectancy of at least 12 weeks.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
• Hemoglobin \> 9.0 g/dl
• Absolute neutrophil count (ANC) \>1,500/mm3
• Platelet count 100,000/ml
• Total bilirubin \< 1.5 times the upper limit of normal
• ALT and AST \< 2.5 x upper limit of normal (\< 5 x upper limit of normal for patients with liver involvement of their cancer)
• Alkaline phosphatase 4 x ULN
• PT-INR/PTT \< 1.5 x upper limit of normal \[Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.\] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.

You may not qualify if:

• Prior systemic treatment for metastatic RCC. It is allowed an adjuvant or neoadjuvant therapy before or after nephrectomy if stopped at least 6 months before the resection of metastatic lesion/s.
• History of cardiac disease: congestive heart failure \>NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (\>= 160 mmHg systolic and/or 90 mmHg diastolic).
• History of HIV infection or chronic hepatitis B or C
• Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
• Symptomatic metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
• History of organ allograft
• Patients with evidence or history of bleeding diathesis
• Patients undergoing renal dialysis
• History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated \> 3 years prior to study entry.
• Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
• Radiotherapy during study or within 3 weeks of start of study drug.
• Major surgery within 4 weeks of start of study
• Autologous bone marrow transplant or stem cell rescue within 4 months of study

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (14)

Istituto Tumori Milano

Milan, Mi, 20156, Italy

Location

Cinzia Ortega

Alba, Italy

Location

Alessandra Bearz

Aviano, Italy

Location

Alfredo Berruti

Brescia, Italy

Location

Saverio Cinieri

Brindisi, Italy

Location

Francesco Atzori

Cagliari, Italy

Location

Rodolfo Passalaqua

Cremona, Italy

Location

Francesco Di Costanzo

Florence, Italy

Location

Vincenzo Emanuele Chiuri

Lecce, Italy

Location

Alessandra Mosca

Novara, Italy

Location

Vittorio Gebbia

Palermo, Italy

Location

Enrico Cortesi

Roma, Italy

Location

Francesco Cognetti

Roma, Italy

Location

Franco Morelli

San Giovanni Rotondo, Italy

Location

Related Publications (1)

• Ljungberg B. The role of metastasectomy in renal cell carcinoma in the era of targeted therapy. Curr Urol Rep. 2013 Feb;14(1):19-25. doi: 10.1007/s11934-012-0293-6.

  PMID: 23212738 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Giuseppe Procopio, MD

  Istituto Tumori Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: October 3, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (14)