Pazopanib Vs. Local Therapy for Renal Cancer With Metastases

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 36
• Participant gender: Both

Summary

The proposed study is a phase II randomized trial testing an innovative concept of comparing local therapy to systemic therapy, e.g. pazopanib, in patients with newly diagnosed limited metastatic RCC. We hypothesize that local therapy can prolong progression-free survival for patients with limited metastasis, and delaying the initiation of systemic therapy does not adversely affect survival. Patient will be stratified by Heng's criteria. Patients that are curable by metastatectomy as well as patients with poor prognosis and high chance of disease dissemination according to the prognostic factors will be excluded.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Last Updated: 2016-11-03

Criteria

Inclusion Criteria:

• Metastatic renal cell carcinoma with limited measurable extracranial metastases

• Limited metastases defined as any number of lesions that can be reasonably treated with local therapy, such as standard SABR.

• Radiographic evidence of metastatic disease. CT should be performed with 30 days of registration.

• Evaluated and deemed eligible by medical oncologist, radiation oncologist, and/or surgeon (if to have surgery).

• Prior surgery or radiation allowed.

• For previous established metastatic status, repeat biopsy is not required.

• Brain metastasis (Brain MRI within 6 months of registration) allowed but all intracranial disease must be treated.

• Adequate hematologic, renal, and hepatic function as defined below:

• leukocytes ≥ 3,000/mcL

• absolute neutrophil count ≥ 1,500/mcL

• platelets ≥ 50,000/mcl

• Creatinine < 2X upper limit of normal

• total bilirubin ≤ 2mg/dL

• AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal

• Age ≥ 18 years.

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy; or

• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

• Ability to understand and the willingness to sign a written informed consent and agrees to undergo image studies and follow up

Exclusion Criteria:

• Subjects received prior systemic therapy, except one line of immuno- or cytokine therapy (e.g. prior IL-2 or any single or combination of checkpoint inhibitors)

• Subjects with potentially curable disease by surgery alone as determined by medical oncologist and surgeon together

• Subjects with high-risk cardiac/vascular disease unable to tolerate pazopanib, e.g. uncontrolled hypertension (>160 systolic blood pressure or >100 diastolic blood pressure); Class III/IV congestive heart failure per NYHA classification; or unstable angina or stroke.

• Subjects with recent major surgery within 4 weeks

• Other contraindications to initiate anti-angiogenic therapy, including history of MI within 8 weeks.

• Subjects with ≥3 unfavorable prognostic factors defined by Heng et al., (KPS <80 %, Hgb < LLN, ANC>ULN, platelet count>ULN, corrected serum calcium >ULN, and time from original diagnosis to initiate targeted therapy <1year), which has median survival 7.8 months and 2-yr survival of 7%.

• Subjects with life expectancy < 6 months.

• Subjects may not be receiving any other investigational agents.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

• Subjects with psychiatric illness/social situations that would limit compliance with study requirements.

• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.