Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03541902
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chromophobe Renal Cell Carcinoma
  • Malignant Neoplasms of Urinary Tract
  • Metastatic Renal Cell Carcinoma
  • Papillary Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions
  • Sarcomatoid Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8
  • Unclassified Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Given PO
  • Sunitinib Malate — DRUG
    Given PO

Study Details

The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer. This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC. The study doctor can explain how the study drugs are designed to work. Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

Start date
May 15, 2018
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (cabozantinib)
    Participants receive cabozantinib PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group 2 (sunitinib malate)
    Participants receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) Evaluated Using RECIST 1.1 Criteria [ Time Frame: From randomization up to the time of disease progression or death up to two years ]

Locations (3)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-
MD Anderson Regional Care Center-KatyHoustonTexas77094-
MD Anderson Regional Care Center-Sugar LandSugar LandTexas77478-

Find similar trials in Houston, TX

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
M D Anderson Cancer Center· Houston, TXMD Anderson Regional Care Center-Katy· Houston, TXMD Anderson Regional Care Center-Sugar Land· Sugar Land, TX

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