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

NCT02472080 | Terminated Phase 2

• 1 other identifier: P130933
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• overall response rate

  overall response rate measured (complete and partial responses) by CT-scan according to RECIST criteria v1.1

  4 months

Secondary Outcomes (7)

• number of adverse events and serious adverse events (AE) according to CTCAE v4.03

  up to 12 month

• Early metabolic response rate on 18F-FDG-TEP/CT

  2 months

• Disease control rate

  4 months

• Time to progression

  up to 36 months

• Progression free survival

  up to 36 months

Study Arms (1)

gemcitabine -oxaliplatine combination

EXPERIMENTAL

Drug: gemcitabine -oxaliplatine combination

Interventions

gemcitabine -oxaliplatine combination DRUG

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

gemcitabine -oxaliplatine combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed differentiated or poorly differentiated thyroid cancer that is metastatic or unresectable
• Patients refractory to radio iodine
• Radiologic evidence of clinically relevant disease progression (as per RECIST 1.1)
• Measurable disease (by RECIST Version 1.1 criteria)
• ECOG performance status of ≤ 1
• Adequate hematologic, renal and liver function
• Negative serum pregnancy test in premenopausal women.
• Signed informed consent
• Other histological subtypes of thyroid tumors: anaplastic, medullary, lymphoma or sarcoma
• Active CNS metastases
• Prior chemotherapy. Patients treated previously with molecular targeted therapies could be included.
• 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"

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié Salpetriere

Paris, 75013, France

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Laurence Leenhardt

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: June 15, 2015
• Study Start: April 7, 2016
• Primary Completion: April 1, 2018
• Study Completion: January 15, 2019
• Last Updated: March 18, 2019

Record last verified: 2018-03

Locations

FR (1)