Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients

NCT02330783 | Unknown Phase 2 DMC

• 1 other identifier: BCH-RCC-141201
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 4

Brief Summary

There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma; Third-line treatment; Sorafenib; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• progress-free survival,PFS

  Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 31 December 2017 cut of date

  2 years

Secondary Outcomes (2)

• overall survival,OS

  3 years

• Safety: adverse events

  1 years

Study Arms (2)

Bevacizumab plus Sorafenib

EXPERIMENTAL

Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid

Drug: Bevacizumab; Drug: Sorafenib

Sorafenib

ACTIVE COMPARATOR

Sorafenib 400mg Bid

Drug: Sorafenib

Interventions

Bevacizumab DRUG

5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)

Also known as: Avstin

Bevacizumab plus Sorafenib

Sorafenib DRUG

400mg twice daily by oral of each 4-week cycle

Also known as: Nexavar

Bevacizumab plus Sorafenib; Sorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years, ≤75 years, male or female
• Advanced renal cellcarcinoma is diagnosed histologically or pathologically
• st line treatment of Sunitinib and 2nd line treatment of Everolimus and no more systemic anti-angiogenesis targeted drug therapy
• Have at least one measurable tumor lesion (Response Evaluation Criteria In Solid Tumors)
• Eastern Cooperative Oncology Group（ECOG) performance scale is 0 or 1
• The expected life span is ≥12 weeks
• No contraindications for chemotherapy, with enough liver function and renal function and normal ECG recording Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L, Hgb≥90g/L Renal function: serum creatinine≤1.5 folds the upper limit of normal (ULN) For patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN
• The patients participate voluntarily and have signed the informed consent form

You may not qualify if:

• Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
• Patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
• Past history of serious heart diseases, including: cardiac function classification ≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
• Patients with a history of HIV infection or active phase of chronic hepatitis B/C
• negative imaging examination result 4 weeks prior to enrollment)
• Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
• A history of allogeneic organ transplantation
• Patients with evidence of hemorrhagic constitution or a past history of hemorrhage
• Patients currently receiving renal dialysis
• Past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
• Patients participating in other clinical trials simultaneously

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (4)

Sun Yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, 100034, China

RECRUITING

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

Cancer Hospital, Fudan University

Shanghai, 200032, China

NOT YET RECRUITING

Related Publications (4)

• Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

  PMID: 24556040 BACKGROUND

• Sosman JA, Puzanov I, Atkins MB. Opportunities and obstacles to combination targeted therapy in renal cell cancer. Clin Cancer Res. 2007 Jan 15;13(2 Pt 2):764s-769s. doi: 10.1158/1078-0432.CCR-06-1975.

  PMID: 17255307 BACKGROUND

• Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, Minasian L, Sarosy G, Kotz HL, Premkumar A, Cao L, McNally D, Chow C, Chen HX, Wright JJ, Figg WD, Kohn EC. Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol. 2008 Aug 1;26(22):3709-14. doi: 10.1200/JCO.2007.10.8332.

  PMID: 18669456 BACKGROUND

• Pal SK, Vogelzang NJ. Sequential treatment strategies and combination therapy regimens in metastatic renal cell carcinoma. Clin Adv Hematol Oncol. 2013 Mar;11(3):146-55.

  PMID: 23598982 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Bevacizumab; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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

• Jun Guo, MD,PHD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinan Sheng, MD

CONTACT

0086-10-88196951; doctor_sheng@126.com

Jun Guo, MD,PHD

CONTACT

0086-10-88196317; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of renal cancer and melanoma

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 5, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

CN (4)