Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer

Not Applicable

• Conditions: -C73 Malignant neoplasm of thyroid gland; Malignant neoplasm of thyroid gland; C73

• Registration Number: PER-086-04
• Lead Sponsor: MGI PHARMA, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-01-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 <2 mg / dL, transaminase aspartate (AST) and alanine transaminase (ALT) <2.5 times the upper normal limit or <5 times the upper normal limit if the patient has liver metastases; Renal: Creatinine clearance (calculated by the Crockroft and Gault method)> 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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified