A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx™ System Plus Chemotherapy as Compared to Chemotherapy Only
Overview
- Phase
- Phase 3
- Intervention
- Talaporfin sodium
- Conditions
- Liver Metastases
- Sponsor
- Light Sciences Oncology
- Enrollment
- 483
- Locations
- 57
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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 with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy.
Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body.
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 treated with Litx™ plus FOLFOX4 versus FOLFOX4 alone; and for patients who have progressed on FOLFOX, they will be treated with Litx™ plus FOLFIRI versus FOLFIRI alone. Stratification upon enrollment by chemotherapy and tumor sum of the longest diameter (SLD) (SLD \< 4 cm or SLD ≥4 cm but ≤7.5 cm).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Litx + Chemotherapy
Intervention: Talaporfin sodium
Litx + Chemotherapy
Intervention: Percutaneous placement of device in liver metastases
Litx + Chemotherapy
Intervention: Interstitial light emitting diodes
Litx + Chemotherapy
Intervention: FOLFOX4 regimen
Litx + Chemotherapy
Intervention: FOLFIRI regimen
Chemotherapy alone
Intervention: FOLFOX4 regimen
Chemotherapy alone
Intervention: FOLFIRI regimen
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Up to 184 weeks
Time from randomization to death