Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma (CROSS-J-RCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yoshihiko TOMITA, Yamagata University
ClinicalTrials.gov Identifier:
NCT01481870
First received: November 17, 2011
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Sorafenib-sunitinib
Drug: Sunitinib-sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Yamagata University:

Primary Outcome Measures:
  • Progression free survival in first-line treatment [ Time Frame: Time of progression in first line treatment ] [ Designated as safety issue: No ]
    From date of randomization until the date of first documented progression of the first line treatment or date of death from any cause, whichever came first, assessed up to 36 months.


Secondary Outcome Measures:
  • Total progression free survival (PFS) in first-line and second-line treatments [ Time Frame: Time of progression in second line treatment ] [ Designated as safety issue: No ]
    From date of randomization until the date of first documented progression of the second line treatment or date of death from any cause, whichever came first, assessed up to 36 months.


Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sorafenib-sunitinib
Sorafenib is first line treatment followed by sunitinib.
Drug: Sorafenib-sunitinib
sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed
Active Comparator: Sunitinib-sorafenib
Sunitinib is first line treatment followed by sorafenib.
Drug: Sunitinib-sorafenib
sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 20-80 years old, both inclusive
  • ECOG performance status of 0, 1, or 2
  • MSKCC risk of favorable or intermediate
  • Histologically confirmed renal cell carcinoma
  • No ischemic heart disease
  • Laboratory findings meet the following criteria:

    1. Respiratory function: %VC, 80% and FEV1.0,70%
    2. Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3
    3. Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin <1.5 x ULN
    4. Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl
    5. Echocardiographic estimation of left ventricular ejection fraction is higher than the lower limit of reference range of each medical institution.

Exclusion Criteria:

  • History of any other malignancy
  • Central nervous system metastases. However, patients who remain asymptomatic, have no new or enlarging lesion in the CNS within 6 months of enrollment in this study, and require no corticosteroids may be enrolled.
  • History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment
  • History of cerebrovascular disorder including transient ischemic attack (TIA)
  • Pregnancy or possible pregnancy at any time during the study
  • Ongoing grade 2 adverse event prior treatment
  • Prior treatment with any anticancer therapy including cytokine therapy such as interferon-alpha and interleukin-2
  • Prior treatment with mTOR inhibitor
  • Prior treatment with sunitinib or sorafenib
  • Treatment with an test drug in a clinical research within 4 weeks of enrollment in this study
  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: NCT01481870

Locations
Japan
Yamagata University Faculty of Medicine
Yamagata, Japan, 990-9585
Sponsors and Collaborators
Yamagata University
Investigators
Principal Investigator: Yoshihiko Tomita, MD Yamagata University Faculty of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Yoshihiko TOMITA, Clinical Professor, Head of Department of Urology, Yamagata University
ClinicalTrials.gov Identifier: NCT01481870     History of Changes
Other Study ID Numbers: CROSS-J-RCC, UMIN000003040
Study First Received: November 17, 2011
Last Updated: February 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Yamagata University:
renal cell carcinoma
sorafenib
sunitinib
crossover

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014