Status:
COMPLETED
Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
Lead Sponsor:
Light Sciences Oncology
Conditions:
Liver Metastases
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer w...
Detailed Description
Randomized, stratified, two arm study: * Litx™ and chemotherapy arm (FOLFOX4 or FOLFIRI) * Chemotherapy only arm (FOLFOX4 or FOLFIRI) For patients who have progressed on FOLFIRI, they will be treate...
Eligibility Criteria
Inclusion
- Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI
- 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 × 10\^9/L ; Platelet Count \> 100 × 10\^9/L ; Hemoglobin \> 90 g/L ; Neutrophils \>1.5 × 10\^9/L ; PT and PTT \< 1.5 Control ; SGOT, SGPT \< 5 × ULN ; GGT \< 5 × ULN ; Alkaline phosphatase \< 5 × ULN ; Bilirubin \< 3 × ULN ; Creatinine \< 1.5 × ULN
Exclusion
- Patients who are candidates for complete surgical resection
- Patients who received bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizumab or cetuximab is prohibited while participating in this study
- Patients who would require more than a total number of 12 light source applications over three Litx™ experimental treatments (no more than 4 light sources per treatment).
- Patients who have a single measurable tumor greater than 7.5 cm 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 of any organ
- Patients 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
483 Patients enrolled
Trial Details
Trial ID
NCT00440310
Start Date
February 1 2007
End Date
October 1 2011
Last Update
August 25 2015
Active Locations (57)
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1
Landeskrankenhaus Feldkirch
Feldkirch, Austria
2
Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel
Vienna, Austria
3
Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology
Mostar, Bosnia and Herzegovina
4
Clinical Centre of the University of Sarajevo, Institute of Oncology
Sarajevo, Bosnia and Herzegovina