Carcinoma of the uterine cervix is the fourth most common malignant neoplasm in women in the United States. The most common site of disease recurrence is local, within the volume covered by standard pelvic irradiation. Using standard radiation therapy, the 5-year pelvic failure rate is 18-39% for Stage II-B, 40-50% for Stage IIIB, and 75% for Stage IV-A disease. The systemic hemoglobin level may influence radiation control of cervix cancer through its association with tissue oxygenation. A 20% increase in hemoglobin concentration from 12 g/dl to 14.4 g/dl is predicted to decrease the hypoxic cell fraction in human tumors by 30% The intratumoral hypoxic cell fraction has recently been found to be prognostic for both overall and disease-free survival in locally advanced cervical cancer patients in a prospective clinical trial, independent of tumor stage, size, grade, or histologic type. Erythropoietin is the primary growth factor promoting proliferation and survival of erythroid progenitor cells as they mature. Anemia in cancer patients is associated with inappropriately low serum erythropoietin levels. Cisplatin is the most extensively studied and most effective single chemotherapeutic agent for squamous cell carcinoma of the cervix. In addition to having an independent cytotoxic effect, cisplatin appears to sensitize malignant cells to radiation by inhibiting their repair of sublethal radiation damage. All patients will receive pelvic irradiation, cisplatin, r-HuEPO and an iron supplement. This study is designed to assess the change in the hemoglobin level of anemic patients with locally advanced cervical carcinoma treated with r-HuEPO and concomitant pelvic external beam radiation and cisplatin. Response and toxicity associated with r-HuEPO, oral iron, pelvic radiation therapy and cisplatin will also be evaluated.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR005096-11
Application #
6411341
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1990-01-14
Project End
2001-11-30
Budget Start
Budget End
Support Year
11
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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