Thyroid CancerPhase 2PantheraNCT00786552
Pemetrexed + Paclitaxel in Patients With Recurrent/Advanced Thyroid Cancer
A Phase 2 study testing pemetrexed + paclitaxel in people with Thyroid Cancer, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed + paclitaxel in patients with recurrent/advanced follicular, papillary or anaplastic thyroid cancer. 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?
- pemetrexed + paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Nov 2013
- 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
Who may be able to join
- Diagnosis of metastatic, histologically proven follicular/papillary or anaplastic thyroid cancer without clinically meaningful surgical or radiotherapeutic options and/or no amenability for radio-iodine therapy and evidence of progressive or symptomatic disease.
- No other forms of chemotherapy or investigational anticancer agents therapy for at least 4 weeks before enrollment in study.
- Performance status of 0 to 2 on the ECOG scale.
- Evidence of measurable disease according to the RECIST criteria.
- Prior radiation therapy and surgery allowed if completed at least 2 weeks prior to study enrollment, prior radioiodine treatment at least 3 months prior to study enrollment and patients must have recovered from the acute toxic effects of the treatment prior to study entry.
- Adequate organ function.
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- No active infection (at the discretion of the investigator) or current central nervous system (CNS) metastases or history of central nervous system metastases or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- No breast feeding nor pregnancy. For women of childbearing potential a negative serum pregnancy-test has to be performed 7 days prior to inclusion into the study.
- No coexisting second malignancy or history of prior malignancy within the last 5 years. (Excluding basal or squamous cell carcinoma of the skin, superficial bladder cancer and in situ carcinoma of the cervix with no evidence of recurrence).
- For men and women of childbearing potential appropriate contraceptive precautions should be taken during the trial and for 3 months afterwards.
- No significant cardiovascular disease in the form of abnormal electrocardiogram (ECG) coupled with clinical features of recent or recurrent symptomatic cardiac disease (including myocardial infarction within the last year, uncontrolled angina, arrhythmia or hypertension, severe congestive heart failure (NYHA >3)).
- No evidence of peripheral neuropathy greater than CTC Grade 1.
- No prior taxane and/or pemetrexed therapy.
- Ability to discontinue administration of acetysalicylate and other nonsteroidal anti-inflammatory agents (NSAID) for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam). Exceptions for selective cyclooxygenase II-inhibitors in analgesic treatment may be discussed.
- No clinically significant effusions (pleural or peritoneal), or albumin <2.5 g/dl at the time of study treatment application. The drainage of effusions prior to study treatment application is possible.
- Inability of oral intake of folic acid or intramuscular vitamin B12 supplementation.
- At least 18 years of age and absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Participation in another trial at the same time is not allowed.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical Center II, University of Kiel
Kiel, 24105
Joerg T Hartmann, MD, +49 431 597 2484, joerg.hartmann@uk-sh.de
About this study
Official title: Phase 2 Trial of Pemetrexed (Alimta™) Combined With Paclitaxel in Patients With Recurrent/Advanced Follicular, Papillary or Anaplastic Thyroid Cancer
The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed + paclitaxel in patients with recurrent/advanced follicular, papillary or anaplastic thyroid cancer.
- Conditions
- Thyroid Cancer
- Being tested
- pemetrexed + paclitaxel
- Keywords
- recurrent/advanced thyroid cancer, papillary or anaplastic thyroid cancer
- Medical subject headings
- Thyroid Neoplasms, Recurrence, Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed + paclitaxelDrug
Pemetrexed 500 mg/m² i.v. over 10 minutes on day 8 Paclitaxel 90 mg/m² i.v. over 60 minutes on day1 and 8
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Experimental | Not described Receives: Drug: pemetrexed + paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of response
Measured: 6 weeks
Secondary outcomes (1)
Toxicity
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2012 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Joerg T Hartmann, MD, Principal investigator, Medical Center II, University of Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786552
- Sponsor's protocol ID
- Panthera
- Acronym
- Panthera
- Status last verified
- Jan 2011
- First submitted
- 5 Nov 2008
- Last updated
- 20 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Pemetrexed (Alimta™) Combined With Paclitaxel in Patients With Recurrent/Advanced Follicular, Papillary or Anaplastic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00786552
- Acronym / sponsor ID
- Panthera / Panthera
- Conditions
- Thyroid Cancer
- Keywords
- recurrent/advanced thyroid cancer, papillary or anaplastic thyroid cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed + paclitaxel in patients with recurrent/advanced follicular, papillary or anaplastic thyroid cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Experimental | Drug: pemetrexed + paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of metastatic, histologically proven follicular/papillary or anaplastic thyroid cancer without clinically meaningful surgical or radiotherapeutic options and/or no amenability for radio-iodine therapy and evidence of progressive or symptomatic disease.
- No other forms of chemotherapy or investigational anticancer agents therapy for at least 4 weeks before enrollment in study.
- Performance status of 0 to 2 on the ECOG scale.
- Evidence of measurable disease according to the RECIST criteria.
- Prior radiation therapy and surgery allowed if completed at least 2 weeks prior to study enrollment, prior radioiodine treatment at least 3 months prior to study enrollment and patients must have recovered from the acute toxic effects of the treatment prior to study entry.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexed + paclitaxelPemetrexed 500 mg/m² i.v. over 10 minutes on day 8 Paclitaxel 90 mg/m² i.v. over 60 minutes on day1 and 8 | Drug | chemotherapy |
Primary outcome
Rate of response
Time frame: 6 weeks
1 secondary outcome
Toxicity
Time frame: weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg T Hartmann, MD principal investigator
Medical Center II, University of Kiel, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed + paclitaxel in people with Thyroid Cancer, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 20 Jan 2011. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joerg T Hartmann, MD (+49 431 597 2484, joerg.hartmann@uk-sh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of response (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2011.