Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer

NCT00408902 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-03014CASE 10805CDR0000518799U01CA062502
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after surgery.

Conditions

Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden)

  The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

  Up to 4 weeks after completion of study treatment

Secondary Outcomes (2)

• Overall Survival

  Followed until progression or death for approximately 3 years

• Progression-free Survival

  Up to 4 weeks after completion of study treatment

Study Arms (1)

TandutinibTreatment

EXPERIMENTAL

Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: tandutinib; Other: laboratory biomarker analysis

Interventions

tandutinib DRUG

Given orally, 500 mg bid daily

Also known as: CT53518, MLN518

TandutinibTreatment

laboratory biomarker analysis OTHER

Correlative studies

TandutinibTreatment

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed RCC of clear cell histology; subjects must have a component of conventional clear cell RCC with or without sarcomatoid features
• Patients must have evidence of metastatic disease and must have had a cytoreductive nephrectomy at least 28 days prior to first day of treatment
• Archival tissue from nephrectomy must be available for correlative studies
• Patients must have measurable disease, defined by RECIST criteria
• Patients must have received at least one prior FDA approved therapy for metastatic renal cell carcinoma with either Sutent, or Nexavar, and may have received up to three prior systemic therapies for metastatic disease; prior cytokine therapy is also permitted
• Prior systemic therapy with other antiangiogenic agents such as Thalidomide, Bevacizumab, or AG013736 is permitted
• Patients must have a life expectancy of \>= 3 months
• Patients must have an ECOG performance status of 0-1 (Karnofsky \>= 70%)
• Patients must be at least 4 weeks from radiation therapy and recovered from all related toxicity
• Absolute neutrophil count \>= 1,500/mcL
• Platelets \>= 100,000/mcL
• Hemoglobin \>= 8.5 g/dl
• Total Bilirubin =\< 1.5 X institutional upper limit of normal
• AST (SGOT)/ALT (SGPT) =\< 3.5 X institutional upper limit of normal
• Alkaline phosphatase =\< 2.5 ULN (=\< 10 x ULN in presence of bone metastasis)

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents
• Patients may not be co-medicated with an agent that causes QTc prolongation
• Patients with a mean QTc \> 500 msec using the Bazett's formula taken from the screening electrocardiogram or history of familial long QT syndrome are ineligible
• Left ventricular ejection fraction (LVEF) \< 40%
• Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Ongoing vomiting, or nausea \>= grade 2 (NCI CTCAE v3.0)
• Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills or absorb oral medications are excluded
• Known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy, myasthenia gravis)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN518 such as Tarceva™, Iressa® and Cardura® XL
• Patients with any CNS metastases or uncontrolled seizure disorder
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
• Any malignancy other than a renal cell carcinoma, with the following exceptions:
• Basal or squamous cell carcinomas of the skin
• Carcinoma in-situ of the uterine cervix

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

tandutinib

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Principal Investigator closed this study due to lack of response and toxicities of drug, therefore overall survival analysis was not done.

Results Point of Contact

• Title: Jorge Garcia MD
• Organization: Case Comprehensive Cancer Center

garciaj4@ccf.org

216-444-7774

Study Officials

• Jorge Garcia

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 7, 2006
• Study Start: November 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 22, 2017
• Results First Posted: February 4, 2015

Record last verified: 2017-10

Locations

US (1)