Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer

NCT00626509 | Unknown Phase 2

• 3 other identifiers: GICR-GIR-1CDR0000588423EUDRACT-2007-005977-67
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective when given before or after surgery in treating kidney cancer. PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to compare how well it works when given before or after surgery in treating patients with metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria

• Adverse events as assessed by NCI CTCAE v3.0

Secondary Outcomes (3)

• Time to progression

• Duration of response

• Overall survival

Interventions

sunitinib malate DRUG

adjuvant therapy PROCEDURE

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Proven metastatic renal cell carcinoma * Measurable disease (according to RECIST criteria) * Eligible for cytoreductive nephrectomy * Primary tumor is considered amenable to surgical extirpation by the attending surgeon * Thrombosis of the inferior vena cava below the epathic veins allowed * No symptomatic brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Adequate hematology and coagulation * Amylase and lipase normal * Adequate hepatic, renal, and cardiac function * Not pregnant * Negative pregnancy test * No uncontrolled hypertension and/or clinically significant cardiovascular events or disease within the past 12 months * No other cancer within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * No prior early nephrectomy due to clinical condition * No prior systemic therapy for renal cell carcinoma (e.g., chemotherapy, hormonal therapy, interferon, interleukin-2, lymphocyte-activated killer cells, or other biological response modifiers) * More than 12 days since prior potent CYP3A4 inducers, including any of the following: * Rifampin * Rifabutin * Carbamazepine * Phenobarbital * Phenytoin * St. John's wort * Efavirenz * Tipranavir * More than 7 days since prior potent CYP3A4 inhibitors, including any of the following: * Ketoconazole * Itraconazole * Clarithromycin * Erythromycin * Diltiazem * Verapamil * Delavirdine * Indinavir * Saquinavir * Ritonavir * Atazanavir * Nelfinavir * No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy * No concurrent participation in any other treatment clinical trial * No concurrent palliative radiotherapy or surgery * No concurrent drugs with proarrhythmic potential, including any of the following: * Terfenadine * Quinidine * Procainamide * Disopyramide * Sotalol * Probucol * Bepridil * Haloperidol * Risperidone * Indapamide * Flecainide * Concurrent bisphosphonate therapy for metastatic bone disease allowed provided therapy was initiated at least 4 weeks prior to the first dose of study drug

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gruppo Italiano Carcinoma Renale: lead

Study Sites (1)

Ospedale Sacro Cuore

Negrar, 37024, Italy

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Marco Venturini, MD

  Ospedale Sacro Cuore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2009-06

Locations

IT (1)