Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 2 week rest period to comprise a complete cycle of 6 weeks. Patients will then continue on Sutent for another cycle of 4 consecutive weeks

Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week washout period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period.

Sunitinib Malate (Sutent)

Antonio Finelli, MD MSc FRCSC

Study Hypothesis: Patients with local renal cell carcinoma who are treated neoadjuvantly with Sutent may show a radiologic response to the study drug (Sutent).

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 evaluate both the safety and effectiveness of Sutent in this patient population.

Sutent will be given at 50 mg once daily for 4 consecutive weeks followed by a 1 week rest period. The dosage may change during the cycle due to possible drug toxicities. The nephrectomy will then take place following a one-week washout period. After surgery, patients will have follow-up visits at 6 weeks and 3 months. Patients will be followed for 3 years after completions to assess late toxicities, time to progression and progression-free survival.

A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

A Phase II, Single Arm, Prospective Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Pfizer

University Health Network, Toronto

Symptoms and General Pathology

Neoplasm Metastasis

Disease Progression

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Celecoxib

Erlotinib Hydrochloride

Participants treated with chemotherapy and radiotherapy

Sutent administered PO QD from days 1 to 28 Two weeks after completion of any chemotherapy, maintenance Sutent in 6 week cycles (consisting of Sutent 50 mg PO QD weeks 1-4 followed by no treatment weeks 5-6) until progression or death If no chemotherapy is planned, maintenance Sutent (as described above) will start on day 43.

sunitinib malate (Sutent)

Radiation is to be delivered to each site over 10 fractions separated by at least 16 hours. Up to 5 sites may be treated

radiotherapy

Max Sung, MD

Cancer is the second leading cause of death in the United States, with approximately 90% of deaths resulting from patients with metastatic spread. Save for notable exceptions such as testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients with limited metastatic deposits (most commonly colon cancer spread to the liver) can be cured with surgery followed by chemotherapy. Therefore, some patients with metastases should be considered for aggressive local therapy (surgery and/or radiation).

Even though chemotherapy has improved significantly, patients treated with conventional chemotherapy and/or biologically targeted therapy are not cured of their disease. For the most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy have major limitations preventing cure of these patients.

Radiation therapy is an effective modality of treating cancer. Until recently, radiation for metastases was used only to relieve symptoms resulting from local tumor growth. Technological advances, including stereotactic radiotherapy, allow for radiation to be more precisely delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that targets tumor blood vessels. It is effective against two types of cancer that rarely respond to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to determine if this is a safe regimen and the best method of combining these treatments. Ultimately, our goal is to cure some patients with previously incurable metastatic cancer with this combination.

Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer

Phase I/II Study of Stereotactic Radiation Therapy and Concurrent and Adjuvant Sutent (SU11248) as Treatment for Oligometastatic Disease

Sunitinib (SU) and radiation (IGRT) doses were sequentially escalated using a ping-pong strategy according to a 3 + 3 design phase 1 study. The starting dose was sunitinib 25 mg and IGRT 40 Gy. MTD reflects the highest dose that did not cause a dose limiting toxicity. Toxicity was in assessed in patients at regular intervals by using the Common Terminology Criteria for Adverse Events criteria (version 3.0). Dose limiting events were defined as any grade 4 or 5 toxicity and unexpected grade 3 toxicity. Expected grade 3 toxicities from radiation include mucositis or esophagitis lasting ≤7 days. Grade 3 metabolic and hematologic toxicities are considered expected events with sunitinib and therefore were not considered DLTs

Number of participants who have no evidence of disease and number of participants with distant metastases.

% of patients experienced one or more grade ≥ 3 toxicities. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4),and death (Grade 5).

Local control was defined as a tumor volume equal to or less than the tumor volume at start of radiotherapy.

Distant control defined as distant metastasis contained outside of the radiation field within months of treatment.

Icahn School of Medicine at Mount Sinai

N=21 participants Patients enrolled between Feb 2007 and May 2008

Phase 1

Patients were eligible if they had histologically or cytological documented advanced solid tumor malignancy with radiographic evidence of 1 to 5 sites of active metastatic disease.

N=26 participants Patients enrolled between February 2008 and September 2010

Phase 2

Phase I

Phase II Advanced Solid Tumor Malignancy

Total

Age, Continuous

Sex: Female, Male

ECOG performance status is an attempt to quantify cancer patients' general well-being and activities of daily life.

0 Fully active, able to carry on all predisease activities with restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Out of bed \> 50%
3. Capable of only limited self-care , confined to bed or chair \> 50% waking hours
4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair

ECOG Performance status

Prior systemic chemotherapy

Prior radiation therapy

Number of metastases

<=3cm

>=3cm

Largest Tumor size

Number of involved organs

Dr. Johnny Kao

Phase 1 - Radiation 40Gy + Sunitinib 25 mg

Phase 1 - Radiation 40Gy + Suniitnib 37.5 mg

Phase 1 - Radiation 50Gy + Sunitinib 37.5mg

Phase 1 - Radiation 50Gy + Sunitinib 50mg

Number of Participants With Dose Limiting Toxicity (DLT)

No evidence of disease

distant metastases

Patients were eligible if they had histologically or cytological documented advanced solid tumor malignancy with radiographic evidence of 1 to 5 sites of active metastatic disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma	NCT00480935	Renal Cell Carc...	Sunitinib Malat...	18 Years -	University Health Network, Toronto
Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer	NCT00463060	Cancer	sunitinib malat... radiotherapy	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for sunitinib malate (sutent)