Neoadjuvant Sunitinib Treatment for Metastatic Clear Cell Renal Cell Carcinoma (RCC)

NCT01069770 | Unknown Phase 2 DMC

• 1 other identifier: Sutent-IIR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to see whether neoadjuvant administration of Sunitinib reduces the size of the primary kidney tumor in patients with metastatic disease undergoing cytoreductive surgery. The study will also assess the safety of neoadjuvant Sunitinib, objective response rate, respectability of primary tumor, quality of life, and survival advantages.

Conditions

Clear Cell Renal Cell Carcinoma; Metastasis

Keywords

Neoadjuvant Therapy; Sunitinib; Clear Cell Renal Cell Carcinoma; Metastasis

Outcome Measures

Primary Outcomes (1)

• Response rate of primary tumor based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria

  within first 1 week (plus or minus 5 days) after 2 cycles of Sunitinib treatment (1 cycle: 4 weeks on + 2 weeks off)

Secondary Outcomes (4)

• Overall survival rate after Sunitinib therapy

  2 years

• Pathologic evaluation after Sunitinib therapy

  After nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)

• Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire (Korean version)

  2 years

• Resectability based on R0 resection rate

  on nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)

Interventions

Sunitinib DRUG

50mg daily(4 weeks on \& 2 weeks off), 2 cycles, until progression or unacceptable toxicity develops

Also known as: Sutent

Eligibility Criteria

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

You may qualify if:

• Biopsy proven RCC with a component of clear cell type histology
• Clinical stage TxNxM+
• At least one site of measurable disease as defined by RECIST criteria
• Potential candidates for cytoreductive nephrectomy
• Favorable or intermittent risk group according to MSKCC risk factor model
• ECOG performance status 0 or 1
• Adequate organ function as defined by:
• AST or ALT less than or equal to 2.5 times the upper limit of normal
• Bilirubin less than or equal to 1.5 times the upper limit of normal
• Absolute neutrophil count (ANC) greater than or equal to 1500/mL
• Platelets greater than or equal to 100,000/mL
• Hemoglobin greater than or equal to 9.0 g/dL
• Serum calcium less than or equal to 12.0 mg/dL
• Serum creatinine less than or equal to 1.5 times the upper limit of normal
• Male or female, 18 years of age or older

You may not qualify if:

• History of another primary malignancy within 5 years, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
• NCI CTCAE grade 3 hemorrhage within 4 weeks of commence of Sunitinib therapy.
• Presence of brain metastases during screening period
• Ongoing cardiac dysrhythmias of NCI CTCAE grade of 2 or more, atrial fibrillation of any grade or prolongation of QTc interval to more than 450 millisecond (msec) for male or more than 470 msec for female
• Hypertension that cannot be controlled by medications
• Concurrent treatment with therapeutic doses of coumadin but low dose of coumadin up to 2 mg orally daily for deep vein thrombosis prophylaxis is allowed.
• Current treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials are allowed.
• Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
• Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing before 7 and 12 days before date of randomization.
• Other severe acute or chronic medical or psychiatric condition of laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
• Any of the following within 12 months prior to study drug administration:
• severe/unstable angina, myocardiac infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
• Known hypersensitivity to Sunitinib
• Women who are breast-feeding ※ Note At screening, resectability of primary tumor itself does not influence on patients enrollment. Physicians only have to describe about the resectability ("resectable" or "unresectable") at screening on their own discretion, but if they decide that primary tumor is "unresectable", the should specify reasons for unresectable status as follows: invasion into neighboring organs, proximity to vital structure or vessels, bulky regional lymph nodes, vascular invasion, burden of metastatic disease, and others.

Sponsors & Collaborators

• Korean Urological Oncology Society: lead
• Pfizer: collaborator

Study Sites (3)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, 137-710, South Korea

RECRUITING

Chungbuk University Hospital

Cheonju, 361-711, South Korea

RECRUITING

Related Links

• Home page of the sponsor's Web site

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sungjoon Hong, M.D., Ph.D

  The Korean Urological Oncology Society

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsoo Chung, M.D.,Ph.D

CONTACT

+82-31-920-2456; cjs5225@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 17, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

KR (3)