EUCTR2006-003759-19-SEActive, not recruitingNot Applicable
Cetuximab and cisplatin in addition to radiotherapy in the treatment of stage IIA-III carcinoma of the uterine cervix - a pilot phase II study.
Department of Gynecological Oncology, University Hospital, Örebro0 sitesStarted: November 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •[1]Histological diagnosis of squamous cell carcinoma and adenocarcinoma of the uterine cervix;
- •[2]Patients with stage IIA-III disease according to the FIGO staging system;
- •[3]>= 18 years old;
- •[4]WHO performance status 0-1;
- •[5]Patients with a good general condition who are considered for primary
- •radiotherapy and expected to tolerate standard radiotherapy combined
- •with weekly cisplatin;
- •[6]Estimated life expectancy of at least 12 weeks;
- •[7]Patient compliance with follow-up routines;
- •[8]Adequate hematological function: WBC >= 3.0 x 10^9/L, neutrophils >=
- •1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 100 g/L;
- •[9]Adequate hepatic and renal function: S-bilirubin, total <= 1.5 x UNL,
- •S-ALAT and S-ASAT <= 3.0 x UNL, S-ALP <= 5.0 x UNL, and S-creatinine <=
- •1.5 x UNL. S-albumin, S-sodium, S-potassium, S-calcium, S-magnesium,
- •S-urea, and S-urate within normal reference limits. GFR >= 60 ml/min
- •(calculated or measured);
- •[10]Written informed consent;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •[11]Prior surgery, radio- or chemotherapy for carcinoma of the uterine cervix;
- •[12]Patients who are considered eligible for primary surgery;
- •[13]Evidence of active infection (at the discretion of the investigator);
- •[14]Pregnancy or breast feeding, childbearing potential not using medically
- •accepted means of contraception;
- •[15]Concurrent systemic disorder incompatible with the study, e.g. serious
- •intercurrent renal, cardiovascular or CNS disease, a major dysfunction in a
- •site of known or assumed toxic effects etc;
- •[16]Known hypersensitivity to any active or inactive ingredient of the study
- •medications, or with hypersensitivity to murine proteins;
- •[17]Second primary malignancy (except an adequately treated basal cell
- •carcinoma of the skin) unless treated, in remission and off active
- •treatment for more than 5 years;
- •[18]Investigator site personnel directly affiliated with the study, or their
- •immediate family;
- •[19]Simultaneous treatment with experimental drugs or participation in a
- •clinical trial within 30 days of study entry;
Investigators
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