A Phase II Trila of Sunitinib Schedule 4/2 vs. Shedule 2/1 as First Line Therapy in Metastatic Renal Cell Carcinoma.

NCT02398552 | Unknown Phase 2 DMC

• 1 other identifier: BCH-RCC-150212
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

Brief Summary

Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. So investigators conducte this randomized, multi-center phase II study to determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the same efficacy in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

metastatic renal cell carcinoma; sunitinib; schedule 2weeks on/1 week off

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 March 2017 cut off date

  2 years

Secondary Outcomes (1)

• The percentage of patients who can get complete response, partial response.

  2 years

Other Outcomes (1)

• Number of adverse events

  1 year

Study Arms (2)

Sunitinib 50mg/day schedule 4/2

ACTIVE COMPARATOR

Sunitinib 50mg/day 4 weeks on/2 weeks off per 6 weeks till disease progression or intolerable toxicity.

Drug: Sunitinib

Sunitinib 50mg/day schedule 2/1

EXPERIMENTAL

Sunitinib 50mg/day 2 weeks on/1 week off per 6 weeks till disease progression or intolerable toxicity.

Drug: Sunitinib

Interventions

Sunitinib DRUG

altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.

Also known as: Sutent

Sunitinib 50mg/day schedule 2/1; Sunitinib 50mg/day schedule 4/2

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 cell carcinoma is diagnosed histologically or pathologically
• Treatment naive at diagnosed
• 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 targeted therapy, 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:

• Patients who have received any systemic therapy including targeted therapy,immunotherapy,chemotherapy etc at diagnosed.
• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (6)

Chinese acadamy of medical science cancer institute & hospital

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Sun Yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Tianjin medical university cancer institute & hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Related Publications (3)

• Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1;27(22):3584-90. doi: 10.1200/JCO.2008.20.1293. Epub 2009 Jun 1.

  PMID: 19487381 BACKGROUND

• Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol. 2010 Jul;66(2):357-71. doi: 10.1007/s00280-009-1170-y. Epub 2009 Dec 5.

  PMID: 19967539 BACKGROUND

• Neri B, Vannini A, Brugia M, Muto A, Rangan S, Rediti M, Tassi R, Cerullo C. Biweekly sunitinib regimen reduces toxicity and retains efficacy in metastatic renal cell carcinoma: a single-center experience with 31 patients. Int J Urol. 2013 May;20(5):478-83. doi: 10.1111/j.1442-2042.2012.03204.x. Epub 2012 Nov 1.

  PMID: 23113655 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jun Guo, MD,PHD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuanliang Cui, MD

CONTACT

0086-10-88196951; 1008ccl@163.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: March 20, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

CN (6)