Bicalutamide + Sunitinib for Kidney Cancer
Recruiting in Palo Alto (17 mi)
Overseen byRoberto Pili, MD/PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: State University of New York at Buffalo
Must not be taking: Immunosuppressants, Steroids
Disqualifiers: Immunodeficiency, Active TB, CNS metastases, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a Phase I/II open-label, efficacy and safety study of bicalutamide in combination with sunitinib in patients with advanced renal cell carcinoma (RCC) who have been treated with a receptor tyrosine kinase inhibitor (RTKI) and experienced disease progression.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any form of immunosuppressive therapy, you must stop these at least 7 days before starting the trial treatment.
What data supports the effectiveness of the drugs Bicalutamide and Sunitinib for kidney cancer?
Research shows that Sunitinib, one of the drugs in the treatment, is effective for kidney cancer, specifically metastatic renal cell carcinoma. It has been shown to improve survival rates and is considered a standard treatment for this type of cancer.
12345Is the combination of Bicalutamide and Sunitinib safe for humans?
Sunitinib, used for kidney cancer, has been studied for safety and can cause side effects like high blood pressure, fatigue, and skin changes. Patients often need dose adjustments to manage these side effects.
678910How does the drug combination of Bicalutamide and Sunitinib differ from other treatments for kidney cancer?
The combination of Bicalutamide and Sunitinib for kidney cancer is unique because it combines a hormone therapy (Bicalutamide) with a targeted therapy (Sunitinib), which is a tyrosine kinase inhibitor that blocks specific proteins involved in cancer growth. This approach may offer a novel mechanism of action compared to standard treatments that typically use Sunitinib alone.
210111213Eligibility Criteria
This trial is for adults with advanced renal cell carcinoma (RCC) who have tried a receptor tyrosine kinase inhibitor but their disease got worse. They need to have measurable disease, be expected to live at least 6 more months, and agree to use contraception. They must also have good organ function and an ECOG performance status of 0-2.Inclusion Criteria
Have measurable disease based on RECIST 1.1
I have taken a pregnancy test within the last 3 days and it was negative.
Be willing and able to provide written informed consent for the trial
+7 more
Exclusion Criteria
I am currently being treated for an infection.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive bicalutamide in combination with sunitinib. Sunitinib is dosed at 2 weeks ON and 1 week OFF schedule, with dose modifications allowed. Bicalutamide is administered at 50 mg daily.
12 weeks (4 cycles of 21 days each)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and response by RECIST criteria.
3 years
Open-label extension (optional)
Participants may opt into continuation of treatment long-term if initial response criteria are met.
Long-term
Participant Groups
The study tests the safety and effectiveness of combining Bicalutamide with Sunitinib in treating RCC patients resistant to previous RTKI therapy. It's an open-label Phase I/II trial where all participants know they're receiving both drugs.
1Treatment groups
Experimental Treatment
Group I: Bicalutamide in combination with SunitinibExperimental Treatment1 Intervention
Bicalutamide 50mg once a day (QD) in combination with sunitinib 37.5mg, 25mg or 50mg QD (2 weeks ON, 1 week OFF). Four or more 21 day-long cycles.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UB/ Great Lakes Cancer CareBuffalo, NY
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Who Is Running the Clinical Trial?
State University of New York at BuffaloLead Sponsor
References
Dose escalation can maximize therapeutic potential of sunitinib in patients with metastatic renal cell carcinoma. [2018]In patients with metastatic renal cell cancer, based on limited evidence, increased sunitinib exposure is associated with better outcome. The survival and toxicity data of patients receiving individualized dose escalated sunitinib therapy as compared to standard management were analyzed in this study.
Sunitinib for the treatment of metastatic renal cell carcinoma. [2022]Sunitinib is an orally administered multitargeted tyrosine kinase inhibitor approved multinationally for the first- and second-line treatment of metastatic renal cell carcinoma (mRCC). The recommended dose of sunitinib is 50mg per day for 4 weeks followed by 2 weeks off-treatment (Schedule 4/2). In a phase III trial in 750 patients with mRCC who had not received prior treatment, sunitinib demonstrated superior efficacy to interferon-α for the first-line treatment of mRCC. Sunitinib doubled progression-free survival compared with interferon-α; furthermore, median OS with sunitinib was greater than 2 years. As a result, sunitinib is now considered a reference standard of care for first-line mRCC treatment in patients at favourable or intermediate prognostic risk and is recommended in treatment guidelines. Additionally, results from an expanded-access programme, in a broad, heterogeneous patient population, confirmed the efficacy of sunitinib. Sunitinib has a distinct and predictable profile of adverse events, most of which are manageable with standard medical interventions. Therapy management strategies, including optimisation of dose and treatment duration and adverse event management can help patients achieve optimal efficacy with sunitinib in clinical practice. To further improve outcomes in patients with mRCC, current trials are evaluating sequencing or combination of targeted agents. The use of sunitinib as adjuvant therapy after nephrectomy and as neoadjuvant therapy is also being assessed. This paper provides an in-depth critical review of sunitinib, with particular focus on the data supporting the use of sunitinib for mRCC.
A phase II study of 2-methoxyestradiol nanocrystal colloidal dispersion alone and in combination with sunitinib malate in patients with metastatic renal cell carcinoma progressing on sunitinib malate. [2022]Current treatment for metastatic renal cell cancer with vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI) have provided improved overall survival, but complete responses are rare. We conducted a multicenter phase II study to evaluate the objective response rate of 2-methoxyestradiol (2ME2 NCD) alone and in combination with sunitinib for patients with metastatic renal cell carcinoma who have progressed on sunitinib alone.
[New therapeutic schedules of Sunitinib: Current evidence regarding the 2:1 scheme.] [2018]In 2006, sunitinib approval by the FDA was a real revolution for the treatment of metastatic renal cell carcinoma (mRCC). However, considerable rates of dose reductions and therapeutic suppressions with the standard regimen (4:2) have forced the search for new schedule proposals in order to optimize the balance between side effects and oncologic efficacy. Among these new proposals, the 2:1 scheme is the one that has generated more expectations.
Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with severe renal impairment or on haemodialysis. [2022]To further investigate the effect of sunitinib, which is currently a standard of care for the treatment of metastatic renal cell carcinoma (mRCC), in patients with severe renal impairment or those undergoing dialysis.
Safety of sunitinib in patients with renal cell carcinoma following nephrectomy. [2022]The safety profile characteristics of sunitinib were evaluated in patients who underwent nephrectomy for kidney cancer.
[Medical treatment of metastatic renal cell carcinoma after the approval and market entry of multitargeted tyrosine kinase inhibitors in Germany]. [2019]To describe the current use and administration of multitargeted tyrosine kinase inhibitors (sunitinib and sorafenib) in the management of metastatic renal cell carcinoma (RCC) and to characterise frequent adverse events.
Management of side effects associated with sunitinib therapy for patients with renal cell carcinoma. [2022]Advances in the understanding of the biology of renal cell carcinoma have led to recent approval of several new agents including drugs that target vascular endothelial growth factor. Sunitinib is an oral tyrosine kinase inhibitor which interferes with multiple intracellular tumorogenic pathways, and has demonstrated impressive antitumor activity in phase II and subsequently improvement in progression free survival in phase III renal cancer trials. We review the unique side effects of sunitinib therapy with emphasis on establishing effective patient education for anticipation and early management of therapy-related side effects.
Frequent dose interruptions are required for patients receiving oral kinase inhibitor therapy for advanced renal cell carcinoma. [2022]Recent advances for patients with advanced or metastatic renal cell carcinoma (RCC) have been shown to improve progression-free survival with both response rates and disease stabilizing activity. Sorafenib, a multikinase inhibitor, and sunitinib, an inhibitor of vascular endothelial growth factor-r and platelet-derived growth factor-r, have been approved by the Food and Drug Administration since 2005/2006. This retrospective analysis of patients treated with both aforementioned kinase inhibitors for advanced RCC presents data related to their antitumor effects as well as safety profile with particular attention to dose interruption and modification requirements.
Sequential sorafenib and sunitinib for renal cell carcinoma. [2018]Sorafenib and sunitinib are 2 tyrosine kinase inhibitors that were recently approved for renal cell carcinoma. In many patients sequential administration of the 2 drugs occurs because of the lack of sustained efficacy of the first agent. We determined the efficacy and safety of sequential administration.
Sunitinib in the treatment of metastatic renal cell carcinoma. [2020]Sunitinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that targets various receptors, including vascular endothelial growth factor receptors (VEGFRs). Sunitinib received approval in 2006 and became a standard treatment option in the first-line treatment of metastatic renal cell cancer (mRCC) after a phase III trial showed superiority compared with interferon alpha (IFN-α). Sunitinib has also shown activity in second-line treatment in several trials. Most of the combination trials with sunitinib with various agents have led to considerable toxicity without improving efficacy. Sunitinib alone causes significant side effects and has a distinct profile with diarrhoea, hypertension, skin effects hypothyroidism, fatigue and nausea of special interest. The recommended dose of sunitinib in mRCC is 50 mg orally daily for 4 weeks, followed by 2 weeks off treatment (4/2 schedule). An alternative 2 weeks on, 1 week off schedule (2/1 schedule) seems to be of similar efficacy and better tolerability and could be more widely used in the future. An intermittent treatment strategy with a stop in remission and re-induction after progression showed efficacy in smaller trials and is currently being evaluated in a phase III trial. Direct comparison of sunitinib with pazopanib in first-line treatment showed a similar efficacy for both TKIs with a distinct toxicity profile. Data from two phase II trials showed that sunitinib has also activity in non-clear cell cancer and is an option due to a lack of better alternatives. Currently, after immune checkpoint inhibitors have shown very promising results in the second-line treatment of RCC, they are being tested in a number of phase III trials in the first-line setting. The future will show the position of sunitinib in the first-line treatment of RCC in the era of the immune checkpoint inhibitors.
Sunitinib (SUTENT) for the treatment of metastatic renal cell carcinoma. [2018]Kidney cancer accounts for approximately 2% of new cancers and conventional treatment with nephrectomy followed by IL-2 or IFN-alpha treatment does not provide long-term survival benefit in many patients. Increased understanding of the pathophysiology of renal cell carcinoma has prompted the development of targeted therapies for patients with this disease, including sunitinib. This paper reviews the most recent efficacy and safety data for sunitinib, as well as currently ongoing and planned studies for this receptor tyrosine kinase inhibitor. Results from a large-scale, long-term, Phase III trial have established sunitinib as the standard of care for first-line treatment of patients with advanced renal cell carcinoma, and it is now the reference standard against which other therapies for this cancer should be evaluated.
Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma. [2022]Both bevacizumab and sunitinib target the vascular endothelial growth factor pathway and demonstrate activity against advanced renal cell carcinoma (RCC). In this phase I study, the maximum-tolerated dose (MTD) and safety of sunitinib in combination with bevacizumab were examined in patients with advanced RCC.