drugset / Trial / NCT02472080

Gemcitabine - Oxaliplatin for Advanced Refractory Thyroid Cancer Patients: a Phase II Study

NCT02472080 ↗

Phase 2 Terminated 21 enrolled Assistance Publique - Hôpitaux de Paris
NaSingle-groupOpen-labelTreatment

Summary

Radioiodine refractory differentiated thyroid cancer is a rare tumor and therapeutic options are limited in this setting. Molecular targeted therapies have recently been developed for progressive disease and demonstrated clinical activity, especially with anti-angiogenic agents. For patients with contra-indication to these agents or in case of progression or toxicity during treatment, chemotherapy is usually proposed but this strategy has not been validated by prospective data. The investigators propose to conduct an open single arm phase 2 study to evaluate response rate according to RECIST 1.1 with GEMOX regimen (gemcitabine - oxaliplatin combination) for advanced radioiodine refractory differentiated thyroid cancer patients after anti-angiogenic agents or in case of contra-indication to anti-angiogenic therapy.

Timeline

Start
2016-04-07
Primary completion
2018-04-01
Completion
2019-01-15

Outcome

Outcome not reported

Stopped: “inefficiency”

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 2 g Intravenous
Subject Oxaliplatin Small molecule 200 mg Intravenous

Indications