Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

May 29, 2013 updated by: AGO Study Group

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Halle, Germany, D-06097
        • Martin Luther Universitaet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Safety
Vital signs
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
Number of treatment failures within 6 months after beginning RCT (stage II)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGO Study Group

Investigators

  • Study Chair: Heinz Koelbl, MD, Martin-Luther-Universität Halle-Wittenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGOSG-OVAR-MO16375-MARCH
  • CDR0000257189 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20217
  • ROCHE-MO16375
  • ROCHE-RO2053859

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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