Pemetrexed + Paclitaxel in Patients With Recurrent/Advanced Thyroid Cancer

NCT00786552 | Unknown Phase 2

• 1 other identifier: Panthera
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

recurrent/advanced thyroid cancer; papillary or anaplastic thyroid cancer

Outcome Measures

Primary Outcomes (1)

• Rate of response

  6 weeks

Secondary Outcomes (1)

• Toxicity

  weekly

Study Arms (1)

chemotherapy

EXPERIMENTAL

Drug: pemetrexed + paclitaxel

Interventions

pemetrexed + paclitaxel DRUG

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

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Medical Center II, University of Kiel

Kiel, 24105, Germany

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Recurrence; Thyroid Carcinoma, Anaplastic

Interventions

Pemetrexed; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Joerg T Hartmann, MD

  Medical Center II, University of Kiel, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joerg T Hartmann, MD

CONTACT

+49 431 597 2484; joerg.hartmann@uk-sh.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2013
• Last Updated: January 20, 2011

Record last verified: 2011-01

Locations

DE (1)