Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Epoetin beta in Treating Anemia in Patients With Cervical Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Supportive care, Treatment Completed Over 18 Pharmaceutical / Industry AGOSG-OVAR-MO16375-MARCH EU-20217, ROCHE-MO16375, ROCHE-RO2053859, NCT00046969

Objectives

1. 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.
2. Compare the safety of these regimens in these patients.
3. Compare the relapse-free and overall survival of patients treated with these regimens.
4. Compare the frequency and localization of relapses and metastases in patients treated with these regimens.
5. Compare the quality of life of patients treated with these regimens.
6. Compare the type, frequency, and degree of adverse events in patients treated with these regimens.
7. Compare the overall response rate in patients treated with these regimens.

Entry Criteria

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

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

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

Expected Enrollment

A total of 80-450 patients will be accrued for this study within 4-22.5 months.

Outcomes

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

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)

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.

Trial Contact Information

Trial Lead Organizations

AGO Ovarian Cancer Study Group

Heinz Koelbl, MD, Protocol chair		Ph: 49-345-557-1847

Registry Information
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)
Trial Start Date		2002-07-10
Registered in ClinicalTrials.gov		NCT00046969 1
Date Submitted to PDQ		2002-02-12
Information Last Verified		2007-03-28

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00046969