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Completed

NCT Number: NCT00570882

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

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.

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Key information

Conditions

Metastatic Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Daegu Catholic University Hospital, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component
  • Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
  • Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study
  • ECOG performance status 2 or better
  • Age 18 years or older
  • Adequate bone marrow, hepatic, and renal function
  • Life expectancy of > 3 months
  • 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

  • Known spinal cord compression or carcinomatous meningitis
  • 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
  • Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy)
  • 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).
  • Pregnancy or breast feeding.
  • Other severe acute or chronic medical or psychiatric condition
  • Prior treatment on sunitinib, sorafenib, or bevacizumab.

Treatment and study plan

Sunitinib 2/1

Drug

Sunitinib 50 mg PO 2 weeks followed by 1 week rest

Sunitinib 4/2

Drug

Sunitinib 50 mg PO 4 weeks followed by 2 week rest

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall response rate

    Time frame: 6 months

    RECIST v.1.1 will be used to assess tumor responses

  2. quality of life

    Time frame: 12 months

    EORTC QLQ C30 and EQ5D will be used to assess the quality of life

  3. Progression free survival

    Time frame: 12 months

  4. Overall survival

    Time frame: 36 months

  5. Adverse events

    Time frame: about 12 months

    CTC AE v.3.0

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2007
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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