A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy

TerminadoFase 3ClinicalTrials.gov

ID: NCT00883116Tipo: INTERVENTIONALInicio: 1 de ago de 2009Fin estimado: 1 de feb de 2014

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Women aged 18 years and older
Histologic or cytologic diagnosis of endometrial carcinoma
Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation.
Karnofsky performance status \>=70
Measurable or nonmeasurable disease that has progressed since last treatment.
If only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology.
Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed.
Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.

Criterios de exclusión

Carcinosarcoma (malignant mixed mullerian tumor)
Endometrial leiomyosarcoma and endometrial stromal sarcomas
Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol)
Known brain metastases
Receipt of prior ixabepilone therapy
Concurrent active infection requiring antibiotics or other therapy
Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months
For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction \<50% as measured by multigated radionuclide angiography or echocardiography
History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
Known human immunodeficiency viral infection
Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
Absolute neutrophil count \<1500/mm\^3
Platelets \<100,000/mm\^3
Hemoglobin \<9 g/dL
Total bilirubin \>1.5\*upper limit of normal (ULN), except for those with Gilbert's disease
Aspartate aminotransferase or alanine aminotransferase \>2.5\*ULN
Serum creatinine \>1.5\*ULN
Grade ≥2 neuropathy (sensory or motor)
No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study

Intervenciones

drug

Ixabepilone

drug

Doxorubicin

drug

Paclitaxel

Ubicaciones

Local Institution

La Rioja, La Rioja Province, Argentina

Local Institution

Salta, Salta Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalR-Pharm

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