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Thyroid CancerPhase 2THYGEMOXNCT02472080

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

A Phase 2 study testing gemcitabine -oxaliplatine combination in people with Thyroid Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
gemcitabine -oxaliplatine combination
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteFrance
Study dates
7 Apr 2016to 15 Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

"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"

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Pitié Salpetriere

    Paris, 75013

Other trials in France

About this study

Official title: Open Labeled Phase II Study Evaluating Efficacy and Safety of Chemotherapy With Gemcitabine - Oxaliplatin Combination for Advanced Refractory Thyroid Cancer Patients

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.

Read the detailed description

The aim is to study efficacy of chemotherapy with 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.

For refractory thyroid cancer patients, in case of contra-indication to molecular targeted therapies or in case of progression or toxicity during treatment, alternative treatments are urgently needed.

Our study could precise if cytotoxic agents should remain a treatment option for refractory thyroid cancer after molecular targeted therapies or in case of contra-indication.

Numerous clinical trials are proposed to evaluate various molecular targeted therapies for refractory thyroid cancer, either conducted by institutional or industrial promoters. In contrast, chemotherapy trials are lacking. As generics are actually available for gemcitabine and oxaliplatin, no industrial support can be expected and prospective evaluation a chemotherapy regimen need to be conducted by an institutional promoter ("Assistance Publique - Hôpitaux de Paris"), supported by many French expert teams through the rare tumor network ""TUTHYREF"".

GEMOX regimen will be administrated intravenously every two weeks in ambulatory setting.

The objective of this study is to analyse the efficacy of chemotherapy with 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.

The primary end point is overall response rate (complete + partial response - CR+PR), according to RECIST 1.1, assessed by local investigator at 4 months.

30 patients will be included in a two steps design (Fleming design). A response rate lower than 15% define the inefficacy level. Minimal efficacy should be 35% response rate.

First step: inclusion of 15 patients. If 2 or less responses are observed: end of study for inefficacy If 6 or more responses are observed: efficacy endpoint has been reached If 3 to 5 responses are observed, additional inclusions are needed. Second step: inclusion of 15 additional patients. Nine responses are expected to define a positive study. Details are presented in statistical section.

The secondary end points are:

  • Safety report according to NCI CTCAE v 4.0 grading scale
  • Early metabolic response rate on 18F-FDG-PET/CT at 2 months
  • Disease control rate (DCR = CR + PR + SD) ≥ 6 months
  • Duration of response
  • Time to progression
  • Progression free survival
  • Overall survival.
  • Evolution of quality of life according to Fact-G and EQ-5D "
Conditions
Thyroid Cancer
Being tested
gemcitabine -oxaliplatine combination
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine -oxaliplatine combinationDrug

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

Study groups in NCT02472080
Study groupRoleWhat they receive
gemcitabine -oxaliplatine combinationExperimentalNot described
Receives: Drug: gemcitabine -oxaliplatine combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate

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

    Measured: 4 months

Secondary outcomes (7)

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

    recording number of adverse events and serious adverse events (AE) according to CTCAE v4.03, during chemotherapy and follow up.

    Measured: up to 12 month

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

    semi-quantitative PET Response Criteria in Solid Tumors PERCIST1.0 "modified" using SUVmax and body-weight. Central reviewing of FDG-PET data by two readers at the end of the study will be done.

    Measured: 2 months

  3. Disease control rate

    Disease control rate (DCR) is defined as the percentage of patients who have achieved complete response (CR), partial response (PR) or stable disease (SD).

    Measured: 4 months

  4. Time to progression

    Time from documentation of tumor response to disease progression or date of death from any cause

    Measured: up to 36 months

  5. Progression free survival

    Time from documentation of tumor response to disease progression or date of death from any cause

    Measured: up to 36 months

  6. Overall survival

    Delay between inclusion and death from any cause

    Measured: up to 36 months

  7. Quality of life

    evolution of quality of life will be assessed by the scores at the FACT-G and EQ-5D surveys (French version)

    Measured: at day 1(week 1, i.e first cycle) and repeated every 28 days (i.e at W5, W9, W13, W17) during chemotherapy and every 3 months until 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2015 (estimated)
  2. Study start7 Apr 2016
  3. Primary completion1 Apr 2018
  4. Study completion15 Jan 2019

Why it stopped: inefficiency

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472080
Sponsor's protocol ID
P130933
Acronym
THYGEMOX
Status last verified
Mar 2018
First submitted
12 May 2015
Last updated
18 Mar 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine -oxaliplatine combination in people with Thyroid Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: inefficiency). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.

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