relapsed ovarian cancer MedDRA version: 6 Classification code 10026662
Conditions
Interventions
Trade Name: Capecitabine
Product Name: Capecitabine
Pharmaceutical Form: Film-coated tablet
Trade Name: Capecitabine
Product Name: Cap
Sponsors
The Royal Marsden NHSF Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Recurrent, histologically verified epithelial ovarian carcinoma. • Measurable disease as assessed by CT in accordance with RECIST guidelines • No more than 2 lines of prior chemotherapy (either as adjuvant or for metastatic disease). • There must be a platinum-free interval of at least 6 months between platinum therapy and start of the next chemotherapy. • A glomerular filtration rate of greater than or equal to 60ml/minute. This can be measured by an EDTA clearance or 24 hour urine collection. • Serum bilirubin3x109/l, neutrophils>1.5x109/l, platelets>100x109/l. • Written informed consent from the patient. 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
Exclusion criteria: • Any medical or psychiatric condition that impairs the patient’s ability to give informed consent. • Uncontrolled angina pectoris, heart failure, or clinically significant uncontrolled cardiac arrhythmias. • Significant abnormal ECG or cardiac history having a LVEF of less than the lower limit of normal for institution as determined by MUGA scan or echocardiogram. • Any other serious uncontrolled medical conditions • Pregnancy or lactation (Any woman of child-bearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment). • Inability to complete the quality of life questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the tolerability of capecitabine 750 mg/m2 d1-21 bd plus carboplatin at AUC 5 on a three weekly cycle. Tolerability will be defined as it is for the maximum tolerated dose in phase 1 studies. If this combination leads to dose limiting toxicity a lower dose of capecitabine will be evaluated (capecitabine 625 mg/m2 d1-21 bd) plus carboplatin (AUC5). 2. To investigate the tolerability of maintenance capecitabine at 750 mg/m2 d1-21 bd continuously for one year. 3. To investigate the response to induction treatment and any additional response to maintenance capecitabine and a comparison between the length of the previous remission with that obtained in this study. ; Secondary Objective: 1. Tumour response to induction treatment with carboplatin and capecitabine according to RECIST criteria and duration of response (relapse free survival). 2. Response to maintenance therapy with capecitabine in all patients with an objective response or stable disease to the induction treatment. 3. Quality of Life ; Primary end point(s): To assess tolerability and toxicity of the combination treatment carboplatin plus capecitabine according to NCI Common Terminology Criteria for Adverse Events v3.0 (http://ctep.cancer.gov/reporting/ctc.html) | — |
Countries
United Kingdom
Outcome results
None listed