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

• Status: Terminated
• Trial end date: 2019-01-15
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Gemcitabine; Oxaliplatin

Criteria

"Main Inclusion criteria

1. Histologically confirmed differentiated or poorly differentiated thyroid cancer that is metastatic or unresectable

2. Patients refractory to radio iodine

3. Radiologic evidence of clinically relevant disease progression (as per RECIST 1.1)

4. Measurable disease (by RECIST Version 1.1 criteria)

5. ECOG performance status of ≤ 1

6. Adequate hematologic, renal and liver function

7. Negative serum pregnancy test in premenopausal women.

8. Signed informed consent

Main Non-Inclusion criteria

1. Other histological subtypes of thyroid tumors: anaplastic, medullary, lymphoma or sarcoma

2. Active CNS metastases

3. Prior chemotherapy. Patients treated previously with molecular targeted therapies could be included.

4. Severe, acute or chronic medical or psychiatric condition or laboratory abnormality which in the judgment of the investigator would make the patient inappropriate for entry into this study"