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

NCT02472080 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

gemcitabine -oxaliplatine combination

gemcitabine (2g/50mL)-oxaliplatine (200mg /40mL) combination, IV,every 2 weeks for 8cycles

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Laurence Leenhardt · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472080 on ClinicalTrials.gov