Epoetin Beta in Treating Anemia in Patients With Cervical Cancer
Palabras clave
Abstracto
Descripción
OBJECTIVES:
- Compare the effectiveness of epoetin beta vs standard care for anemia management, in terms of increased hemoglobin levels and the correlation with reduced relapse/treatment failure rate, in patients with stage IIB, III, or IVA cervical cancer treated with cisplatin and radiotherapy.
- Compare the safety of these regimens in these patients.
- Compare the relapse-free and overall survival of patients treated with these regimens.
- Compare the frequency and localization of relapses and metastases in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the type, frequency, and degree of adverse events in patients treated with these regimens.
- Compare the overall response rate in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are stratified according to country, disease stage, and brachytherapy technique. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients also undergo high-dose rate, low-dose rate, or boost brachytherapy. Patients receive cisplatin IV beginning on day 1 of radiotherapy and continuing weekly for 6 weeks. Patients also receive epoetin beta subcutaneously 3 times a week beginning 2 weeks before radiotherapy and continuing for 8 weeks.
- Arm II: Patients undergo radiotherapy and brachytherapy and receive cisplatin as in arm I.
Quality of life is assessed at baseline, after the last treatment, and at 3 months.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 80-450 patients will be accrued for this study within 4-22.5 months.
fechas
| Verificado por última vez: | 02/28/2007 |
| Primero enviado: | 10/02/2002 |
| Inscripción estimada enviada: | 01/25/2003 |
| Publicado por primera vez: | 01/26/2003 |
| Última actualización enviada: | 05/28/2013 |
| Última actualización publicada: | 05/29/2013 |
| Fecha de inicio real del estudio: | 06/30/2002 |
| Fecha estimada de finalización del estudio: | 05/31/2007 |
Condición o enfermedad
Intervención / tratamiento
Biological: epoetin beta
Drug: cisplatin
Radiation: brachytherapy
Radiation: radiation therapy
Fase
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | DISEASE CHARACTERISTICS: - Histologically confirmed stage IIB, III, or IVA cervical cancer - No chorion carcinoma or neuroendocrine small cell carcinoma - Previously untreated disease - Must be scheduled to undergo radiotherapy and receive cisplatin as primary therapy - Hemoglobin 8.0-13.0 g/dL - No relevant acute bleeding within the past 3 months, including anemia caused by gross bleeding from tumor - No distant metastasis - No positive para-aortic lymph nodes PATIENT CHARACTERISTICS: Age - Over 18 Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - See Disease Characteristics - WBC greater than 3,000/mm3 - Platelet count greater than 100,000/mm3 - No hemolytic anemia - No transferrin saturation less than 20% that cannot be treated with IV iron - No hemoglobinopathies (i.e., sickle cell disease or thalassemia of all types) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Transaminases no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine clearance greater than 60 mL/min Cardiovascular - No chronic heart failure - No New York Heart Association class II-IV heart disease - No uncontrolled arterial hypertension (systolic blood pressure at least 170 mmHg, diastolic blood pressure at least 100 mmHg) - No prior deep vein thrombosis - No thrombocytosis Other - No vitamin B12 deficiency - No folic acid deficiency - No newly diagnosed (unstable) epilepsy - No acute infection - No other malignancy within the past 5 years except basal cell carcinoma in situ - No known peripheral neuropathy or moto-sensory neurotoxicity grade 2 or greater - No impaired hearing grade 2 or greater - No hypersensitivity to benzyl alcohol, benzoic acid, benzalkonium chloride, or any excipients of cisplatin preparations - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior epoetins or related compounds Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy for cervical cancer Surgery - Not specified Other - At least 30 days since prior investigational drugs - No prior systemic antineoplastic therapy for cervical cancer - No other concurrent investigational drugs |
Salir
Medidas de resultado primarias
1. Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I) [undefined]
2. Overall survival after RCT (stage II) [undefined]
Medidas de resultado secundarias
1. Progression/relapse-free survival [undefined]
2. Overall response rate to RCT [undefined]
3. Overall survival after RCT (stage I) [undefined]
4. Frequency and localization of relapses and/or metastases [undefined]
5. Change in hemoglobin from baseline during therapy [undefined]
6. Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia [undefined]
7. Type, frequency, and degree of adverse events [undefined]
8. Safety [undefined]
9. Vital signs [undefined]
10. Number of treatment failures within 6 months after beginning RCT (stage II) [undefined]
