NCT00786552UnknownPhase 2
Phase 2 Trial of Pemetrexed (Alimta™) Combined With Paclitaxel in Patients With Recurrent/Advanced Follicular, Papillary or Anaplastic Thyroid Cancer
University Hospital Schleswig-Holstein1 site in 1 country47 target enrollmentStarted: November 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Rate of response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
chemotherapy
Experimental
Intervention: pemetrexed + paclitaxel (Drug)
Outcomes
Primary Outcomes
Rate of response
Time Frame: 6 weeks
Secondary Outcomes
- Toxicity(weekly)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Study of Pemetrexed and Bevacizumab in Patients With Head and Neck CancerCancerNCT00222729University of Pittsburgh42
Completed
Phase 2
Pemetrexed and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube CancerRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaNCT01001910Albert Einstein College of Medicine22
Completed
Phase 1
Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal CancerPrimary Peritoneal CancerOvarian CancerNCT00489359Eli Lilly and Company86
Completed
Phase 2
Pemetrexed in Patients With Soft Tissue SarcomaSarcomaNCT00427466University Hospital Tuebingen54
Completed
Phase 2
Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane TherapyBreast NeoplasmsBreast CancerNCT00063570Eli Lilly and Company73