None listed
Conditions
Interventions
Anaplastic thyroid cancer Type of group
Irofulven 0.4 mg / kg administered by intravenous injection on Days 1 to 15 of a 28-day cycle + Capecitabine 2000 mg / m2 / day orally, twice a day, Days 1 to 14 and in the morning of Day 15
Group name:Locally advanced / metastatic cancer differentiated Type of group
Irofulven 0.4 mg / kg administered by intravenous injection on Days 1 to 15 of a 28-day cycle + Capecitabine 2000 mg / m2 / day orally, twice a day, Days 1 to 14 and in the morning of Day 15
Sponsors
MGI PHARMA, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients must sign an informed consent approved by the IRB / EC. • Patients must be at least 18 years of age. • Patients must have, at least, a life expectancy of 3 months. • Patients must have a Functional Status of O to 2 on the scale of the Eastern Cooperative Oncology Group (Eastern Cooperative Oncology Grpup). • Patients must have histologically confirmed anaplastic thyroid cancer or histologically confirmed differentiated thyroid cancer from one of the following subtypes: papillary, follicular or Hürthle cell. • Patients with differentiated thyroid cancer should not have received more than one prior chemotherapeutic regimen for such cancer. • Patients should have free trachea and respiratory tract. • Patients should have measurable disease defined by the RBCIST criteria with at least one lesion 2 cm long by conventional CT techniques or, at least, 1 cm by computed spiral tomography (spiral CTscan). • Patients must have discontinued prior chemotherapy at least 4 weeks before and at least 6 weeks before in the case of nitrosoureas and mitomycin before the first dose of the study treatment and must have recovered from any toxic effect of the treatment. treatment. • Patients must have discontinued previous radiation therapy at least 4 weeks before the first dose of treatment under study and must have recovered from any toxic effects of treatment. • Patients must have discontinued therapy at least 3 months before the first dose of the study therapy if no absorption has been observed with the last treatment or at least 6 months before the first dose of the therapy. study therapy, if absorption was observed with the last treatment. Patients must have recovered from any haematological or pulmonary adverse effects of treatment. • Patients with locally advanced / metastatic differentiated thyroid cancer should not be gaining any clinical benefit from previously administered therapy. • Patients must have adequate organic functions defined as; Bone marrow: platelets> 100 x 10 9 / L, hemoglobin> 9 g / dL, absolute neutrophil count (ANC)> 1.5 x 10 9 / L; Hepatic: Bilimbine 60 mL / min; Metabolic: calcium <2.7 mmol / L • Those patients with reproductive potential should use medically acceptable method of contraception. • Women of childbearing age must have had a negative pregnancy test result on the screening test. Women are not considered to have reproductive potential if they have entered menopause more than two years ago or are sterile due to having undergone surgery.
Exclusion criteria
Exclusion criteria: • Patients should not have had a history of retinopathy. • Patients should not be pregnant or breastfeeding. • Patients must not have suffered any medical / systemic or psychiatric disorder incompatible with the study (at the discretion of the investigator) • Patients should not be affected by any active infection (at the discretion of the researcher) • Patients must not have undergone external radiotherapy and radiation at> 30% of the bone marrow at any time prior to enrollment. • Patients should not currently have metastases without controlling the CNS. • Patients should not have been previously treated with Irofulven or previous treatment with Capecitabine, prolonged infusion of 5-FU (duration of infusion> 5 days) or other specific fluoropyrimidines for the treatment of thyroid cancer. • Patients should not have a significant history of gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that could compromise the absorption of Capecitabine or be unavailable orally. • Patients must not have been in treatment with another investigational substance or have participated in another clinical study within 28 days prior to the first dose of study treatment or during the study period. • Patients should not have been treated with therapeutic doses of coumarin derivatives within 14 days prior to the first dose of study treatment or during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The response to the tumor will be evaluated using the RECIST criteria. Measurable disease: the presence of, at least, a measurable lesion. Measure:Target response levels to the tumor Timepoints:Evaluated every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time elapsed from the date of the first dose of irofulven to the date of the first documented progression of the disease, death from any cause or loss of trace for follow-up. Measure:Time to disease progression Timepoints:The time to progression of the disease will be counted at the date of the last follow-up visit for those patients whose disease has not progressed or at the date of death for patients who have died from other causes that were not progression of the disease. ; Outcome name:defined as the time elapsed from the date of the first dose of irofulven to the date of death from any cause or lost trace for follow-up. Measure:Total survival Timepoints:Total survival will be counted as of the date of the last follow-up visit for those patients who are still living. ; Outcome name:It is measured from the date of the first dose of irofulven to the date of the first evaluation of CR or PR for patients who have a confirmed CR or PR. Measure:Time to answer Timepoints:date of the first evaluation of CR or PR for patients who have a confirmed CR or PR. ; Outcome name:Defined as the time between the first evaluation of a CR or PR to the first progression or death from any cause for those patients who have a CR or PR confirmed. Measure:Duration of the response Timepoints:The duration of response will be counted at the date of the last follow-up visit for those patients whose disease has not progressed or at the date of death for patients who have died from other causes that were not disease progression. | — |
Countries
Argentina, France, Peru, Russian Federation, Ukraine, United States
Outcome results
None listed