Mapatumumab, Cisplatin and Radiotherapy for Advanced Cervical Cancer

Inclusion criteria

• Patients with histologically or cytologically confirmed stage IB2, IIA2, IIB, III, and IVA cervical cancer, according to the FIGO classification
• Adequate bone marrow, renal and liver function:

• Absolute neutrophil count ≥ 1.5 x 109 /L.
• Platelet count ≥ 100 x 109 /L.
• Serum creatinine level ≤ 1.5 x upper limit of normal (ULN).
• Total bilirubin < 1.25 x ULN.
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN.
• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
• Age 18 years or older.
• Life expectancy of ≥ 12 weeks.
• Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study and follow-up procedures.

Exclusion criteria

• Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complications or reduces the possibility of assessing clinical effect.
• Cytotoxic agent, hormonal therapy, or radiation therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin-C) prior to day 1, cycle 1; investigational agent within 4 weeks prior to day 1, cycle 1.
• Need for concomitant anticancer therapy (surgery, radiation therapy, chemotherapy, immunotherapy, radiofrequency ablation) or other investigational agents during the study treatment period.
• Major surgery within 4 weeks before enrollment; minor surgery (except for insertion of vascular access device) within 2 weeks before enrollment; or not yet recovered from the effects of the surgery.
• Systemic steroids within 1 week before enrollment except steroids used as part of an antiemetic regimen or maintenance-dose steroids for non-cancerous disease.
• History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment.
• Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids.
• Known human immunodeficiency virus infection.
• Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure within 6 months before enrollment.
• Pregnant female or nursing mother.