A Phase 2 interventional study of Pazopanib and Everolimus in Clear Cell Renal Carcinoma, sponsored by Netherlands Working Group on Immunotherapy of Oncology. Completed at 17 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.
Sponsored by Netherlands Working Group on Immunotherapy of Oncology · Phase 2, Interventional, and Treatment
In this study will be examined whether alternating treatment between two classes of drugs (TKI's and m-TOR inhibitors) postpones or prevents drug resistance in patients with renal cancer.
Current practice is to treat with VEGFR-TKI or mTOR inhibitors until progression and then continue with the next active agent. From a biological perspective, TKI's will most likely activate compensatory pathways which, may ultimately lead to the development of resistance. Recent studies suggest that resistance to treatment with TKI may be reversible after stopping treatment. There is therefore a rationale to alternate treatment to prevent or delay the occurrence of resistance.
Our hypothesis is that alternating active agents in clear cell renal carcinoma (ccRCC) may reduce side effects, improve tolerability and compliance of treatment and prolong progression free survival and overall survival compared to the standard of care.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 101 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Netherlands Working Group on Immunotherapy of Oncology is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of one or more of the following cardiovascular conditions within the past 6 months:
In the experimental arm (Arm A) alternating treatment will consist of 8 weeks of Pazopanib 800 mg qd alternated by 8 weeks of Everolimus 10 mg qd until first progression(PD per RECIST 1.1)followed thereafter by Pazopanib (when PD after 8 weeks of Everolimus)or Everolimus (when PD after 8 weeks of Pazopanib) monotherapy until second progression.
Drug: Pazopanib · Drug: Everolimus
The comparative arm (Arm B) will be the standard regimen of Pazopanib (800 mg qd continuously) until progression, followed thereafter by Everolimus (10 mg qd continuously) until progression.
Drug: Pazopanib · Drug: Everolimus
Tablet 800mg qd til progression
Also known as: Votrient, L01XE11
tablet 10 mg qd til progression
Also known as: Afinitor, L01XE10
tablet 800mg qd, alternating schedule: 8 weeks Pazopanib, 8 weeks Everolimus
Also known as: Votrient, L01XE11
tablet 10mg qd, alternating schedule: 8 weeks Pazopanib, 8 weeks Everolimus
Also known as: Afinitor, L01XE10
Everolimus 10mg qd monotherapy until second progression (PD per RECIST 1.1)when first progression after 8 weeks of Pazopanib in alternating regimen
Also known as: Afinitor, L01XE10
Pazopanib 800mg qd monotherapy until second progression (PD per RECIST 1.1) when first progression after 8 weeks of Everolimus in alternating regimen
Also known as: Votrient, L01XE11
Progression free survival
Time frame: Randomization until earliest date of disease progression (according RECIST 1.1 criteria) or death, an expected average of one year
Time to second progression
Time between first progression and second progression (PD) per RECIST 1.1 on Everolimus monotherapy (when PD after 8 weeks Pazopanib) or Pazopanib monotherapy (when PD after 8 weeks Everolimus) as second line treatment in experimental arm and time to progressive disease on Everolimus as second line treatment in comparative arm.
Time frame: Time between first and second progression, an expected average of five months
Change in Quality of life assessed by the FKSI-DRS and EORTC QLQ-C30 questionnaires compared to baseline
Quality of life will be assessed bi-monthly by using the FACT Kidney Symptom Index (FKSI)-Disease Related Symptom (DRS)and the EORTC QLQ-C30 questionnaire. The symptoms covered by the FKSI-DRS include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. The EORTC QLQ-C30 questionnaire evaluates five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact).
Time frame: From randomization until one month after ceasing study medication, an expected average of 18 months
Toxicity reported as number/percentage of patients with adverse events
Adverse events will be reported according Criteria for Adverse Events v4.0 (NCI CTCAE v4)
Time frame: From randomization until one month after ceasing study medication, an expected average of 18 months
Overall survival
Time frame: Time between randomization and death, an estimated average of 2-5 years
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Netherlands Working Group on Immunotherapy of Oncology