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

• ClinicalTrials.gov Identifier: NCT00786552
• Recruitment Status: Unknown
• First Posted: November 6, 2008
• Last Update Posted: January 20, 2011
• Sponsor: University Hospital Schleswig-Holstein
• Information provided by: University Hospital Schleswig-Holstein

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Toxicity [ Time Frame: weekly ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 Hospital Schleswig-Holstein

Investigators

• Principal Investigator: Joerg T Hartmann, MD; Medical Center II, University of Kiel, Germany

More Information

• Responsible Party: Prof. Dr. med. J. T. Hartmann, University of Kiel
• ClinicalTrials.gov Identifier: NCT00786552
• Other Study ID Numbers: Panthera
• First Posted: November 6, 2008
• 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:

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; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors