Health Condition 1: null- Liver metastases in patients with colorectal cancer (that is patients who have cancer of the colon or rectum that has spread to the liver)
Conditions
Interventions
Intervention1: Talaporfin sodium: One group of patients receives talaporfin sodium applied to one or more liver metastases through percutaneous access (through the skin) in combination with standard c
Sponsors
Light Sciences Oncology Inc
Eligibility
Inclusion criteria
Inclusion criteria: Note: No upper age limit for this clinical trial, (indicated as 18 years and above) 1. Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI. 2. Biopsy proven evidence of colorectal cancer. 3. At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed). 4. ECOG Performance Status 0-2. 5. Life expectancy of at least 16 weeks. 6. 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. 7. Understanding and ability to sign written informed consent. 8. 18 years of age or more. 9. Adequate hematologic, liver, and renal functions.
Exclusion criteria
Exclusion criteria: 1. Patients who are candidates for complete surgical resection 2. 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. 3. 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). 4. Patients who have a single measurable tumor greater than 7.5 cm in the longest diameter in any organ. 5. Target lesions irradiated within 3 months of randomization. 6. Patients with tumor involvement in greater than 50% of parenchyma of the liver. 7. Evidence of major vessel invasion of any organ. 8. 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. 9. Known sensitivity to porphyrin-type drugs or known history of porphyria. 10. 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. 11. Concurrent participation in another clinical trial involving experimental treatment. 12. Any concurrent disease or condition that in the opinion of the investigator impairs the patient?s ability to complete the trail 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: Time being measured from randomization to documented Progression of Death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: Time being measured from Randomization to Death | — |
Countries
India
Contacts
Public ContactDr Prashant Pandya
Reliance Life Sciences Pvt. Ltd.
Outcome results
None listed