Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

Sponsor

AGO Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00046969

Collaborator

(none)

450

Enrollment

Location

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Cervical Cancer	Biological: epoetin beta Drug: cisplatin Radiation: brachytherapy Radiation: radiation therapy	Phase 4

Detailed 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

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

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Management Of Anemia Under RadioChemotherapy (MARCH): An Open, Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy (Radiotherapy Plus Cisplatin)

Study Start Date :

Jul 1, 2002

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I) []
Overall survival after RCT (stage II) []

Secondary Outcome Measures

Progression/relapse-free survival []
Overall response rate to RCT []
Overall survival after RCT (stage I) []
Frequency and localization of relapses and/or metastases []
Change in hemoglobin from baseline during therapy []
Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia []
Type, frequency, and degree of adverse events []
Safety []
Vital signs []
Number of treatment failures within 6 months after beginning RCT (stage II) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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