Pemetrexed + Paclitaxel in Patients With Recurrent/Advanced Thyroid Cancer (Panthera)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00786552
First received: November 5, 2008
Last updated: January 19, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Thyroid Cancer
Drug: pemetrexed + paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Rate of response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 47
Study Start Date: November 2008
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786552

Contacts
Contact: Joerg T Hartmann, MD +49 431 597 2484 joerg.hartmann@uk-sh.de

Locations
Germany
Medical Center II, University of Kiel Recruiting
Kiel, Germany, 24105
Contact: Joerg T Hartmann, MD    +49 431 597 2484    joerg.hartmann@uk-sh.de   
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Joerg T Hartmann, MD Medical Center II, University of Kiel, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. med. J. T. Hartmann, University of Kiel
ClinicalTrials.gov Identifier: NCT00786552     History of Changes
Other Study ID Numbers: Panthera
Study First Received: November 5, 2008
Last Updated: January 19, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
recurrent/advanced thyroid cancer
papillary or anaplastic thyroid cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Paclitaxel
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 19, 2014