Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia

Completed · Phase 3

Conditions studied: Anemia, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Drug Toxicity, Radiation Toxicity, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer

In brief

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

Key facts

Study ID: NCT00017004
Run by: Gynecologic Oncology Group
People needed: 114
Starts: 2001-08-01
Last updated by the study team: 2017-08-09

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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
Performance status - GOG 0-3
See Disease Characteristics
Absolute neutrophil count at least 1,500/mm\^3
Platelet count at least 100,000/mm\^3
Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal
Creatinine no greater than 2.0 mg/dL
No uncontrolled hypertension
No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)
No active hemolysis
No history of pulmonary embolism
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

Where it is running

Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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