NCT00046969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 30, 2013

Status Verified

March 1, 2007

First QC Date

October 3, 2002

Last Update Submit

May 29, 2013

Conditions

AnemiaCervical Cancer

Keywords

anemiastage IIB cervical cancerstage III cervical cancerstage IVA cervical cancercervical adenosquamous cell carcinomacervical squamous cell carcinomacervical adenocarcinoma

Outcome Measures

Primary Outcomes (2)

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

  • Overall survival after RCT (stage II)

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Interventions

epoetin betaBIOLOGICAL
cisplatinDRUG
brachytherapyRADIATION
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Martin Luther Universitaet

Halle, D-06097, Germany

Location

MeSH Terms

Conditions

AnemiaUterine Cervical Neoplasms

Interventions

epoetin betaCisplatinBrachytherapyRadiotherapy

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • Heinz Koelbl, MD

    Martin-Luther-Universität Halle-Wittenberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Study Completion

June 1, 2007

Last Updated

May 30, 2013

Record last verified: 2007-03

Locations

DE(1)