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AnemiaPhase 4NCT00046969

Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

A Phase 4 study testing epoetin beta, cisplatin and brachytherapy in people with Anemia and Cervical Cancer, run by AGO Study Group at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Anemia, Cervical Cancer
What is being tested?
epoetin beta, cisplatin and brachytherapy
Type of treatment
Surgery or procedure
How many people
450 participants
Where
1 siteGermany
Study dates
Jul 2002to Jun 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Martin Luther Universitaet

    Halle, D-06097

Other trials in Germany

About this study

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)

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.

Read the 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.

Being tested
epoetin beta, cisplatin, brachytherapy, radiation therapy
Keywords
anemia, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, cervical adenocarcinoma
Medical subject headings
Anemia, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epoetin betaBiological

  • cisplatinDrug

  • brachytherapyRadiation

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)

  2. Overall survival after RCT (stage II)

Secondary outcomes (10)

  1. Progression/relapse-free survival

  2. Overall response rate to RCT

  3. Overall survival after RCT (stage I)

  4. Frequency and localization of relapses and/or metastases

  5. Change in hemoglobin from baseline during therapy

  6. Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia

  7. Type, frequency, and degree of adverse events

  8. Safety

  9. Vital signs

  10. Number of treatment failures within 6 months after beginning RCT (stage II)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2002
  3. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00046969
Sponsor's protocol ID
AGOSG-OVAR-MO16375-MARCH
Other IDs
CDR0000257189, EU-20217, ROCHE-MO16375, ROCHE-RO2053859
Status last verified
Mar 2007
First submitted
3 Oct 2002
Last updated
30 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing epoetin beta, cisplatin and brachytherapy in people with Anemia and Cervical Cancer, run by AGO Study Group at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00046969.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.

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