Pre-Surgical Sutent for Kidney Cancer

Not currently recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticancer therapy

Disqualifiers: Organ allografts, Brain metastases, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking Sutent® (sunitinib malate) before surgery can help control kidney cancer, specifically renal cell carcinoma. Researchers are also assessing the safety of this treatment for patients. The trial may suit those with metastatic clear cell kidney cancer who plan to have a kidney removed and have not received prior treatments for this cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot receive any other systemic therapy for renal cell cancer while participating. You can continue taking bisphosphonates and megestrol acetate.

Is there any evidence suggesting that sunitinib is likely to be safe for humans?

Research has shown that Sunitinib, the treatment under study, has been safely used for kidney cancer. It is already approved for treating advanced kidney cancer. Previous studies have found that most patients tolerate it well. Some individuals might experience side effects, but these are usually mild and manageable.

For example, one study found that Sunitinib can help control cancer growth by stopping blood flow to tumors, working effectively without causing significant issues for patients. Another study examined its use before and after surgery, confirming its safety and effectiveness in similar situations.

Overall, evidence suggests that Sunitinib is a safe option for treating kidney cancer, even when used before surgery. However, as with any treatment, individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Sunitinib before surgery for kidney cancer because it offers a unique approach compared to the standard treatments like surgery alone or other drugs such as sorafenib or pazopanib. Unlike these options, Sunitinib works by targeting specific proteins that help the cancer grow and spread, potentially reducing the size of the tumor before surgery. This targeted action not only helps in shrinking the tumor but might also improve surgical outcomes by making the tumor easier to remove. Additionally, the timing of Sunitinib administration—28 days before surgery—could allow for more precise and effective intervention against the cancer's progression.

What evidence suggests that Sutent might be an effective treatment for kidney cancer?

Research has shown that sunitinib effectively treats kidney cancer by stopping tumor growth and even shrinking them. It has proven particularly successful in treating advanced kidney cancer and is a top choice for metastatic renal cell carcinoma, a type of kidney cancer that spreads. In this trial, participants will receive sunitinib before undergoing nephrectomy. One study found that sunitinib reduced tumor size in 17 out of 20 patients before surgery, suggesting its potential in managing the disease pre-surgically. ^{2 3 5 6 7}

Who Is on the Research Team?

Eric Jonasch, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with metastatic clear cell renal cell carcinoma who are fit for surgery to remove a kidney. They must be in good physical condition, not pregnant, and willing to use birth control. People with recent surgeries, other cancers within 2 years (except certain skin or in situ carcinomas), brain tumors or metastases, uncontrolled blood pressure, serious heart conditions, or those on certain other treatments can't join.

Inclusion Criteria

I am not pregnant, as confirmed by a recent test.

I have metastatic clear cell kidney cancer and am eligible for surgery to remove my kidney.

Your blood and organ functions must be within normal ranges, including specific levels for white blood cells, platelets, hemoglobin, bilirubin, creatinine, and liver enzymes.

Exclusion Criteria

I have not had cancer before, except for skin cancer or cancers that have been treated and I've been disease-free for 2 years.

I have not had cancer treatment for kidney cancer, but radiation more than 2 weeks ago is okay.

You are pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle 1

Participants receive sunitinib malate daily for 4 weeks followed by 2 weeks of rest

6 weeks

1 visit (in-person) at the beginning of the cycle

Surgery and Treatment Cycle 2

Surgery to remove the tumor followed by resumption of sunitinib malate treatment

6 weeks

1 visit (in-person) for surgery and follow-up

Subsequent Treatment Cycles

Continuation of sunitinib malate treatment with regular follow-up visits

up to 5 years

Visits every 6 weeks for the first 6 cycles, then every 12 weeks

Post Treatment Evaluation

Follow-up visit 30 days after the last dose of sunitinib malate

1 month

1 visit (in-person)

Long-Term Follow-Up

Regular contact to check disease status every 6-12 weeks for 2 years, then every 6 months up to 5 years

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Nephrectomy
• Sunitinib

Trial Overview The study tests if taking Sutent (sunitinib malate) before kidney removal surgery can help manage kidney cancer better. It's also looking at how safe sunitinib malate is when used this way.

How Is the Trial Designed?

Group I: Sunitinib + Nephrectomy Experimental Treatment 2 Interventions

Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

Sunitinib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor

Approved in European Union as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor
• Pancreatic Neuroendocrine Tumors

Approved in Canada as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor

Approved in Japan as Sutent for:

• Renal Cell Carcinoma
• Gastrointestinal Stromal Tumor

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Sunitinib is an effective treatment for metastatic renal cell carcinoma (mRCC) in Japan, showing high therapeutic response and prolonged survival, but it has a distinct toxicity profile that requires careful monitoring.

The most common severe side effect of sunitinib is myelotoxicity, particularly thrombocytopenia, affecting 73% of patients, with 36.8% experiencing grade 3 or higher toxicity, indicating the need for dose adjustments and individualized treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of sunitinib-associated adverse events]. Kanda, H., Masui, S., Yamada, Y., et al.[2018]

Sunitinib malate is a multi-kinase inhibitor approved for treating advanced renal cell carcinoma and other specific tumors, showing modest antitumor activity in ovarian cancer based on Phase I and II trials.

The drug has an acceptable safety profile, but further research is needed to better understand its toxicity and to explore combination therapies for enhanced efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of sunitinib as a therapy in ovarian cancer. Leone Roberti Maggiore, U., Valenzano Menada, M., Venturini, PL., et al.[2018]

Sunitinib (Sutent) is an effective treatment for metastatic renal cell carcinoma (RCC), showing a 37% response rate and 48% stable disease, making it the preferred first-line therapy for this cancer.

Sunitinib also demonstrates efficacy in gastrointestinal stromal tumors (GIST) with an 8% response rate and 70% stable disease, contributing to a median survival of 20 months, and shows moderate activity in breast cancer and non-small cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma and various other solid tumors. Polyzos, A.[2018]

Sunitinib is an effective treatment for advanced metastatic renal cell carcinoma (mRCC), showing a significant improvement in progression-free survival compared to interferon-alpha, with 11 months for sunitinib versus 5 months for interferon-alpha in a Phase III study.

In Phase II trials, sunitinib demonstrated a partial response rate of 40% and 34% as a second-line therapy for mRCC patients who did not respond to previous cytokine treatments, indicating its efficacy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sunitinib (Sutent): a novel agent for the treatment of metastatic renal cell carcinoma. Chouhan, JD., Zamarripa, DE., Lai, PH., et al.[2018]

In a Phase III trial involving treatment-naive patients with metastatic renal cell carcinoma (mRCC), sunitinib significantly improved progression-free survival compared to IFN-α, demonstrating its efficacy as a first-line treatment.

Sunitinib is effective even in challenging cases, such as patients with non-clear cell histology or those who are refractory to other treatments, and while it has common side effects like fatigue and hypertension, these may also indicate better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of sunitinib in renal cell carcinoma: where are we now? Czarnecka, AM., Szczylik, C., Rini, B.[2018]

Sunitinib, a targeted oral medication for advanced renal cell carcinoma (mRCC), significantly improves progression-free survival, achieving a median of 11 months compared to just 5 months with interferon-alpha in a Phase III trial involving previously untreated patients.

The drug is generally well tolerated, with manageable side effects, making it a recommended first-line treatment option for patients with favorable or intermediate prognostic risk in international guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sunitinib for the management of advanced renal cell carcinoma. Escudier, B.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01024205

Sunitinib Malate Before and After Surgery in Treating ... PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after surgery works in treating patients with metastatic kidney cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5896861/

Sunitinib in the treatment of renal cell carcinoma In addition, sunitinib has been shown to have a direct inhibitory effect on tumor growth by promoting tumor apoptosis, as well as an indirect inhibitory effect ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00480935

A Study of Neoadjuvant Sutent for Patients With Renal Cell ... The study is looking at the neoadjuvant (pre-surgery) administration of Sutent in patients with localized kidney cancer. The purpose of this research is also to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3105599/

Prospective clinical trial of preoperative sunitinib in patients ... Sunitinib decreased the size of primary RCC in 17 of 20 patients, and future trials can be considered to evaluate the use of neoadjuvant sunitinib to maximize ...

5. withpower.com withpower.com/trial/phase-3-carcinoma-renal-cell-5-2008-69fa0

Pre-Surgical Sutent for Kidney Cancer · Info for Participants It is particularly effective in treating advanced kidney cancer and is considered the gold standard for metastatic renal cell carcinoma, offering significant ...

6. sutent.com sutent.com/advanced-RCC

Advanced Kidney Cancer | SUTENT® (sunitinib malate) SUTENT has been proven effective in the treatment of advanced renal cell carcinoma (RCC). A clinical trial proved that SUTENT is more effective than IFNα.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00459979

Sunitinib in Treating Patients With Kidney Cancer That ... RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.