Renal Cell Carcinoma Clinical Trial
Official title:
A Phase II Single Arm Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Tarceva™ (Erlotinib Hydrochloride) and Rapamune™ (Sirolimus) in the Treatment of Metastatic Renal Cell Carcinoma.
Verified date | March 2014 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney cancer.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent to participate in this study. - Histological diagnosis of renal cell carcinoma. - Age greater or equal 18 years. - Eastern Cooperative Oncology Group (ECOG) Performance status of 2 or better. - Life expectancy of at least 3 months. - Failure or intolerance to previous treatment with Sutent® and/or Nexavar®. - Most recent systemic treatment at least 1 month from the beginning of treatment. - Most recent local treatment (surgery or irradiation) > 2 weeks from the beginning of treatment. - At least one site of measurable disease by CT scan or MRI (RECIST criteria). - Baseline hemoglobin >9 g/dl, platelets > 100,000/mm3, absolute neutrophil count (ANC >1500/mm3. Exclusion Criteria: - Previous treatment with Tarceva™, Iressa™, Rapamune™, temsirolimus or everolimus. - Untreated metastasis to the central nervous system. - Previous solid organ, bone marrow or stem-cell transplant. - Known AIDS or HIV infection. - Symptomatic or poorly controlled chronic heart failure. - Chronic renal failure requiring dialysis on a regular basis. - Chronic liver failure. - Serum aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase or bilirubin >1.5 x the upper limit of normal for the local laboratory. - Pregnant or breast-feeding women. - Other invasive malignant diseases within 5 years (other than squamous or basal cell carcinoma of the skin). - Inability to provide informed consent - Any other serious and/or unstable medical, psychiatric, or other condition considered by the P.I. to preclude safe or reasonably compliant participation in the protocol. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Genentech, Inc. |
United States,
Gemmill RM, Zhou M, Costa L, Korch C, Bukowski RM, Drabkin HA. Synergistic growth inhibition by Iressa and Rapamycin is modulated by VHL mutations in renal cell carcinoma. Br J Cancer. 2005 Jun 20;92(12):2266-77. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival | Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance in obtaining scans, unequivocal clinical progression or the initiation of another medication for the treatment of renal cell carcinoma. | Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks. | No |
Secondary | Overall Survival | For all subjects who had not died at the time of statistical analysis, duration of survival will was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the magnitude of the treatment effect as described for progression-free survival. | Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks. | No |
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
|