Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

Status Completed

Clinical Trial Summary

RATIONALE: Epoetin beta may stimulate red blood cell production to prevent or control anemia in patients treated with chemotherapy and radiation therapy.

PURPOSE: Randomized phase IV trial to determine the effectiveness of epoetin beta in treating anemia in patients who are receiving cisplatin and radiation therapy for stage IIB, stage III, or stage IVA cervical cancer.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00046969
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 4
Start date	July 2002
Completion date	June 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06223308` - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Terminated	`NCT03367871` - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer	Phase 2
Active, not recruiting	`NCT04537156` - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)	Phase 3
Recruiting	`NCT03668639` - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin	Phase 2/Phase 3
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Withdrawn	`NCT04806945` - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer	Phase 3
Active, not recruiting	`NCT04185389` - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn	`NCT03007771` - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia	Phase 1
Completed	`NCT03384511` - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.	Phase 4
Recruiting	`NCT05107674` - A Study of NX-1607 in Adults With Advanced Malignancies	Phase 1
Completed	`NCT05120167` - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy	N/A
Recruiting	`NCT05483491` - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer	Phase 1
Recruiting	`NCT05736588` - Elimisha HPV (Human Papillomavirus)	N/A
Completed	`NCT05862844` - Promise Women Project	N/A
Recruiting	`NCT04934982` - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)	N/A
Recruiting	`NCT03876860` - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis	N/A
Completed	`NCT03652077` - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies	Phase 1
Completed	`NCT00543543` - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)	Phase 3
Terminated	`NCT04864782` - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer	Phase 2/Phase 3
Recruiting	`NCT04226313` - Self-sampling for Non-attenders to Cervical Cancer Screening	N/A