Study of Sunitinib Administered as 4/2 vs. 2/1 Schedule in Advanced Renal Cell Carcinoma (RCC)

September 22, 2014 updated by: JLee, Asan Medical Center

A Randomized Phase II Trial Of Sunitinib Administered Daily For 4 Weeks, Followed By 2-Week Rest Vs. 2-Week On And 1-Week Off In Metastatic Renal Cell Carcinoma

This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of
        • Daegu Catholic University Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component
  2. Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
  3. Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study
  4. ECOG performance status 2 or better
  5. Age 18 years or older
  6. Adequate bone marrow, hepatic, and renal function
  7. Life expectancy of > 3 months
  8. Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

  1. Known spinal cord compression or carcinomatous meningitis
  2. Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
  3. Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy)
  4. Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).
  5. Pregnancy or breast feeding.
  6. Other severe acute or chronic medical or psychiatric condition
  7. Prior treatment on sunitinib, sorafenib, or bevacizumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sunitinib 4/2
Sunitinib 50 mg PO 4-week on and 2-week off
Drug: Sunitinib 4/2
Sunitinib 50 mg PO 4 weeks followed by 2 week rest
Experimental: Sunitinib 2/1
Sunitinib 50 mg PO 2-week on 1-week off
Drug: Sunitinib 2/1
Sunitinib 50 mg PO 2 weeks followed by 1 week rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
Time Frame: 12 months
From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 12 months
12 months
Overall survival
Time Frame: 36 months
36 months
Overall response rate
Time Frame: 6 months
RECIST v.1.1 will be used to assess tumor responses
6 months
quality of life
Time Frame: 12 months
EORTC QLQ C30 and EQ5D will be used to assess the quality of life
12 months
Adverse events
Time Frame: about 12 months
CTC AE v.3.0
about 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Jae-Lyun Lee, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 22, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOSG_AMC_0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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