Anemia Clinical Trial
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
Verified date | August 2017 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | |
Est. primary completion date | May 15, 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 - No recent (within the past 3 months) or uncontrolled seizure disorder - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - See Disease Characteristics - See Disease Characteristics |
Country | Name | City | State |
---|---|---|---|
United States | Gynecologic Oncology Group of Arizona | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | Canadian Cancer Trials Group, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams | Up to 5 years | ||
Secondary | Overall survival | Up to 5 years | ||
Secondary | Local control, coded as successful if any relapse or disease progression is is contained within the pelvic field | Up to 5 years |
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