E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with recurrent liver metastases from colorectal cancer who have progressed on either FOLFOX4 or FOLFIRI |
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E.1.1.1 | Medical condition in easily understood language |
Cancer of the colon (gut) which is metastatic to the liver |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050035 |
E.1.2 | Term | Metastatic colon cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The study objective is to demonstrate the safety of Litx therapy and the efficacy of Litx+chemotherapy versus chemotherapy alone in treating patients with recurrent liver metastases from colorectal cancer as determined by overall survival and progression free survival (PFS) |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI or equivalent regiments in which oral capecitabine was used as an alternative to fluorouracil (5-FU) given intravenously; • Biopsy proven evidence of colorectal cancer • At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed) • ECOG Performance Status 0-2 • Life expectancy of at least 16 weeks • At least 30 days must have elapsed since the completion of any prior antineoplastic therapy and the patient must have recovered from acute side effects before day 0 • Understanding and ability to sign written informed consent • 18 years of age or more • Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2.5 x 109/L Platelet Count > 100 x 109/L Hemoglobin > 90 g/L Neutrophils >1.5 x 109/L PT and PTT < 1.5 Control SGOT, SGPT < 5 x ULN GGT < 5 x ULN Alkaline phosphatase < 5 x ULN Bilirubin < 3 x ULN Creatinine < 1.5 x ULN |
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E.4 | Principal exclusion criteria |
• Patients who are candidates for complete surgical resection • Patients who received bevacuzimab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of Bevacuzimab or Cetuximab is prohibited while participating in this study. • Patients who would require more than 12 light applications over three Litx experimental treatments • Patients who have a single measurable tumor greater than 7.5 cm in the longest diameter in any organ. • Target lesions irradiated within 3 months of randomization. • Patients with tumor involvement in greater than 50% of parenchyma of the liver. • Evidence of major vessel invasion in any organ. • Patient with any non-colorectal cancers except for adequately treated basal or • squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient has been disease-free for > 3 years, or other cancer from which the patient has been disease-free for > 5 years. • Known sensitivity to porphyrin-type drugs or known history of porphyria. • Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study. • Concurrent participation in another clinical trial involving experimental treatment. • Any concurrent disease or condition that in the opinion of the investigator impairs the patient’s ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator’s opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial’s data. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 277 events have been reported |
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E.5.2 | Secondary end point(s) |
Progression Free Survival (PFS) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 277 events have been reported |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Litx therapy + chemotherapy vs chemotherapy alone |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Bosnia and Herzegovina |
Croatia |
Germany |
India |
Italy |
Latvia |
Poland |
Russian Federation |
Serbia |
Ukraine |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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All patients will be monitored for survival from time of last randomization until death from any cause or 180 weeks, whichever occurs first. Once the patient has confirmed progressive disease or reached 128 weeks, no more visits are required. The patient will be followed for survival by phone and/or email at 12-week intervals. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |