E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The rationale of this randomized double blind study is to investigate the efficacy of topical eye treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in the lacrimal tears will be washed away by the repetitive use of eye drops. Eye drops containing corticosteroids have an anti-inflammatory effect and may prevent the formation of fibrosis. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To asses the efficacy of topical eye (maxidex versus lacrystat) treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis.
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E.2.2 | Secondary objectives of the trial |
Incidence and grading of dacryostenosis in each arm at 3, 6 and 26 weeks. Incidence and grading of epiphora in each arm at 3,6,9 and 26 weeks. Correlation between Docetaxel concentration in tear fluid at 3 weeks and development and grading of dacryostenosis.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with locally advanced or metastatic breast cancer receiving weekly Docetaxel chemotherapy with rest weeks in between at regular time intervals. The timing of rest weeks between cycles is not restricted. Examples of allowed regimens are Docetaxel 36 mg/m2 day 1 and 8 every 3 weeks; day 1, 8, 15 every 4 weeks; day 1, 8, 15, 21, 28, 35, 42, 49 every 10 weeks. Dosing and rest weeks can be further modified depending on the clinical situation, but dose intensity should be at least 60 mg/m2 every 3 weeks during the 9 week treatments for eligibility. Combination with other chemotherapy (such as capecitabine) is allowed. Capability to administer eye drops (either by patient or companion). Written informed consent. 18 years or more no evidence of pregnancy
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E.4 | Principal exclusion criteria |
Systemic criteria: o History of treatment with Docetaxel.
Eye criteria: o Ocular surface, corneal, conjunctival or eyelid disease. o Soft contact lens wearers o Glaucoma Lacrimal criteria: - Hypersecretion of tears: ocular surface, corneal, conjunctival or eyelid disease. - Functional blockage of lacrimal drainage without anatomical obstruction (facial nerve palsy, displacement of the lower lacrimal punctum from the lacrimal lake, involutional lower eyelid laxity). - Anatomical obstruction of lacrimal drainage system: 1. Primary acquired nasolacrimal duct obstruction (PANDO) 2. Secondary: o Infection (Herpes simplex, Herpes Zoster, Fungal keratitis, Actinobacter). o Trauma o Drug induced: after topical treatment with idoxuridine, pilocarpine, epinephrine or phospholine jodide. 3. Congenital
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E.5 End points |
E.5.1 | Primary end point(s) |
The incidence and grading of dacryostenosis in each arm at 9 weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Docetaxel treatment is continued or stopped after 9 weeks depending on the clinical decision of the treating oncologist which takes into account tumor response and other chemotherapy related toxicities. The topical eye treatment is continued throughout Docetaxel administration and can be stopped 2 weeks after the last Docetaxel adminstration.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |