Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborators:	National Cancer Institute (NCI) NCIC Clinical Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00017004

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.

Condition	Intervention	Phase
Anemia Cervical Cancer Drug/Agent Toxicity by Tissue/Organ Radiation Toxicity	Biological: epoetin alfa Drug: cisplatin Procedure: quality-of-life assessment Radiation: brachytherapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 G/L With Erythropoietin Versus Above 100 G/L Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Erythropoietin Cisplatin Epoetin alfa

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	August 2001
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL with epoetin alfa vs maintaining Hgb levels above 10.0 g/dL without epoetin alfa on progression-free survival, overall survival, and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin.
Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to stage (IIB vs IIIB vs IVA), method of brachytherapy (low-dose vs high-dose), and surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.
Arm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.

Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of last brachytherapy, and every 3 months for 2 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Stage IIB, IIIB, or IVA
- Primary, previously untreated disease
Hemoglobin less than 14 g/dL at presentation
Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy
Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy
No involvement of the lower third of vagina
No carcinoma of the cervical stump

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

GOG 0-3

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No uncontrolled hypertension
No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)
No active hemolysis

Pulmonary:

No history of pulmonary embolism

Other:

No septicemia or severe infection
No circumstances that would preclude study participation
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No history of hypersensitivity to epoetin alfa or human albumin
No diagnosis of vitamin B_12 or folic acid deficiency
No recent (within the past 3 months) or uncontrolled seizure disorder
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017004

Show 44 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

NCIC Clinical Trials Group

Investigators

Study Chair:	Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)	Edmond Odette Cancer Centre at Sunnybrook
Study Chair:	Peter S. Craighead, MD	Tom Baker Cancer Centre - Calgary

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068641, GOG-0191, CAN-NCIC-CX4
Study First Received:	June 6, 2001
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00017004 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

radiation toxicity
drug/agent toxicity by tissue/organ
stage III cervical cancer
stage IIB cervical cancer
stage IVA cervical cancer

cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
anemia

Additional relevant MeSH terms:

Epoetin Alfa
Radiation-Sensitizing Agents
Cisplatin
Hematinics
Antineoplastic Agents
Hematologic Diseases

Therapeutic Uses
Hematologic Agents
Physiological Effects of Drugs
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009