Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00005507

Trial Description

start of 1:1-Block title

Title

Phase 2 Trial of Pemetrexed (Alimta™) Combined With Paclitaxel in Patients With Recurrent/Advanced Follicular, Papillary or Anaplastic Thyroid Cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Panthera

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005507
  •   2013/12/06
  •   2008/11/05
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00786552  (ClinicalTrials.gov)
  •   Panthera  (University of Schleswig-Holstein)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Thyroid Cancer
  •   C73 -  Malignant neoplasm of thyroid gland
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: pemetrexed + paclitaxel
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Rate of response; time frame: 6 weeks

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Toxicity; time frame: weekly

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2008/11/30
  •   47
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

[---]*

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Schleswig-Holstein
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Medical Center II, University of Kiel, Germany
    • Joerg T Hartmann, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Joerg T Hartmann, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.