Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases

Phase 3

Completed

Conditions: Liver Metastases
Neoplasm Metastasis
Colorectal Neoplasms
Neoplasm Recurrence, Local

Interventions: Drug: Talaporfin sodium
Drug: FOLFOX4 regimen
Procedure: Percutaneous placement of device in liver metastases
Device: Interstitial light emitting diodes
Drug: FOLFIRI regimen

Registration Number: NCT00440310

Lead Sponsor: Light Sciences Oncology

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 483

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
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Litx + Chemotherapy	Talaporfin sodium	-
Litx + Chemotherapy	FOLFIRI regimen	-
Chemotherapy alone	FOLFOX4 regimen	-
Litx + Chemotherapy	FOLFOX4 regimen	-
Chemotherapy alone	FOLFIRI regimen	-
Litx + Chemotherapy	Percutaneous placement of device in liver metastases	-
Litx + Chemotherapy	Interstitial light emitting diodes	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 184 weeks	Time from randomization to death

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (57): Landeskrankenhaus Feldkirch
🇦🇹
Feldkirch, Austria
Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel
🇦🇹
Wien, Austria
Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology
🇧🇦
Mostar, Bosnia and Herzegovina
Clinical Centre of the University of Sarajevo, Institute of Oncology
🇧🇦
Sarajevo, Bosnia and Herzegovina
General Hospital Karlovac
🇭🇷
Karlovac, Croatia
Clinical Centre Zagreb, Clinical Oncology
🇭🇷
Zagreb, Croatia
General Hospital "Sveti Duh"
🇭🇷
Zagreb, Croatia
University Hospital Dubrava
🇭🇷
Zagreb, Croatia
Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I
🇩🇪
Aalen, Germany
Helios Kliniken - Innere Medizin und Kardiologie
🇩🇪
Borna, Germany
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Landeskrankenhaus Feldkirch
🇦🇹Feldkirch, Austria