Renal Cell Carcinoma Clinical Trial
Official title:
Phase II, Single Arm Trial of Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.
- Participants will receive study treatment as an outpatient. Study treatment will be
given in 3-week cycles.
- Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each
treatment cycle.
- Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each
treatment cycle.
- Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be
performed: physical exam, performance status assessment and blood work. Before
receiving gemcitabine on day 8 the following will be performed: physical exam,
performance status assessment and blood work. Every 3 cycles a CT scan will be
performed to measure the tumor.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04987203 -
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
|
Phase 3 | |
| Recruiting |
NCT06391879 -
Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
|
||
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
| Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
| Completed |
NCT02853344 -
Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
|
Phase 2 | |
| Terminated |
NCT04088500 -
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT05070637 -
Circulating Tumor Cell Reducing No-touch Nephrectomy
|
N/A | |
| Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
| Not yet recruiting |
NCT06049030 -
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT01358721 -
Phase I Biomarker Study (BMS-936558)
|
Phase 1 | |
| Active, not recruiting |
NCT04503148 -
Anesthesia and Cancer Study: Renal Cell Carcinoma
|
N/A | |
| Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
| Not yet recruiting |
NCT05808608 -
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03323710 -
Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT03052504 -
Prospective Versus Retrospective Complications in Radical Cystectomy and Nephrectomy
|