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Trial record 1 of 1 for:    NCT00786552
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Pemetrexed + Paclitaxel in Patients With Recurrent/Advanced Thyroid Cancer (Panthera)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786552
Recruitment Status : Unknown
Verified January 2011 by University Hospital Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : November 6, 2008
Last Update Posted : January 20, 2011
Information provided by:
University Hospital Schleswig-Holstein

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: pemetrexed + paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Pemetrexed (Alimta™) Combined With Paclitaxel in Patients With Recurrent/Advanced Follicular, Papillary or Anaplastic Thyroid Cancer
Study Start Date : November 2008
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: chemotherapy Drug: pemetrexed + paclitaxel
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

Primary Outcome Measures :
  1. Rate of response [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: weekly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786552

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Contact: Joerg T Hartmann, MD +49 431 597 2484

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Medical Center II, University of Kiel Recruiting
Kiel, Germany, 24105
Contact: Joerg T Hartmann, MD    +49 431 597 2484   
Sponsors and Collaborators
University Hospital Schleswig-Holstein
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Principal Investigator: Joerg T Hartmann, MD Medical Center II, University of Kiel, Germany
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Responsible Party: Prof. Dr. med. J. T. Hartmann, University of Kiel Identifier: NCT00786552    
Other Study ID Numbers: Panthera
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: January 2011
Keywords provided by University Hospital Schleswig-Holstein:
recurrent/advanced thyroid cancer
papillary or anaplastic thyroid cancer
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors