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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Korean Urological Oncology Society.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Korean Urological Oncology Society
ClinicalTrials.gov Identifier:
NCT01069770
First received: February 12, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Clear Cell Renal Cell Carcinoma
Metastasis
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Sunitinib Therapy in Patients With Metastatic Clear Cell Type Renal Cell Carcinoma Patients: a Prospective Study

Resource links provided by NLM:


Further study details as provided by Korean Urological Oncology Society:

Primary Outcome Measures:
  • Response rate of primary tumor based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: within first 1 week (plus or minus 5 days) after 2 cycles of Sunitinib treatment (1 cycle: 4 weeks on + 2 weeks off) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival rate after Sunitinib therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Pathologic evaluation after Sunitinib therapy [ Time Frame: After nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment) ] [ Designated as safety issue: No ]
  • Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire (Korean version) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Resectability based on R0 resection rate [ Time Frame: on nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: July 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sunitinib
    50mg daily(4 weeks on & 2 weeks off), 2 cycles, until progression or unacceptable toxicity develops
    Other Name: Sutent
Detailed Description:

Primary objectives :

1. Response rate of primary tumor based on RECIST criteria

Secondary objectives :

  1. Resectability based on R0 resection rate (negative margin)
  2. Toxicities of therapy with neoadjuvant Sunitinib in renal cell carcinoma
  3. Quality of life assessed by EORTC QLQ-C30 questionnaire Korean version
  4. To assess the efficacy of neoadjuvant therapy of Sunitinib by evaluating time to progression
  5. Overall survival rate after Sunitinib therapy
  6. Pathologic evaluation after Sunitinib therapy: the change of necrosis and microvessel density
  Eligibility

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

Inclusion Criteria:

  • 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
  • Women of childbearing potential must NOT be pregnant (as confirmed by a negative pregnancy test)
  • Signed informed consent form indicating that the patient or acceptable representative has been informed of all parts of the trial prior to Sunitinib administration (enrollment)
  • Willingness and ability to comply with study procedures

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069770

Contacts
Contact: Jinsoo Chung, M.D.,Ph.D +82-31-920-2456 cjs5225@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Jinsoo Chung, M.D., Ph.D.    +82-31-920-2456    cjs5225@ncc.re.kr   
Chungbuk University Hospital Recruiting
Cheonju, Korea, Republic of, 361-711
Contact: Wun-Jae Kim, M.D., Ph.D.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 137-710
Principal Investigator: Hyun Moo Lee, M.D.,Ph.D.         
Sponsors and Collaborators
Korean Urological Oncology Society
Pfizer
Investigators
Principal Investigator: Sungjoon Hong, M.D., Ph.D The Korean Urological Oncology Society
  More Information

Additional Information:
No publications provided

Responsible Party: Sung-Goo Chang/ President, Korean Urological Oncology Society
ClinicalTrials.gov Identifier: NCT01069770     History of Changes
Other Study ID Numbers: Sutent-IIR
Study First Received: February 12, 2010
Last Updated: June 21, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Urological Oncology Society:
Neoadjuvant Therapy
Sunitinib
Clear Cell Renal Cell Carcinoma
Metastasis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014