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Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

Primary Purpose

Anemia, Cervical Cancer

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
epoetin beta
cisplatin
brachytherapy
radiation therapy
Sponsored by
AGO Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring anemia, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, cervical adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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 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

Sites / Locations

  • Martin Luther Universitaet

Outcomes

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)

Full Information

First Posted
October 3, 2002
Last Updated
May 29, 2013
Sponsor
AGO Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00046969
Brief Title
Epoetin Beta in Treating Anemia in Patients With Cervical Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AGO Study Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Cervical Cancer
Keywords
anemia, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, cervical adenocarcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
epoetin beta
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Number of treatment failures within 6 months after beginning radiochemotherapy (RCT) (stage I)
Title
Overall survival after RCT (stage II)
Secondary Outcome Measure Information:
Title
Progression/relapse-free survival
Title
Overall response rate to RCT
Title
Overall survival after RCT (stage I)
Title
Frequency and localization of relapses and/or metastases
Title
Change in hemoglobin from baseline during therapy
Title
Quality of life as assessed by the Functional Assessment of Cancer Therapy-Anemia
Title
Type, frequency, and degree of adverse events
Title
Safety
Title
Vital signs
Title
Number of treatment failures within 6 months after beginning RCT (stage II)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Koelbl, MD
Organizational Affiliation
Martin-Luther-Universität Halle-Wittenberg
Official's Role
Study Chair
Facility Information:
Facility Name
Martin Luther Universitaet
City
Halle
ZIP/Postal Code
D-06097
Country
Germany

12. IPD Sharing Statement

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Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

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