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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Light Sciences Oncology
ClinicalTrials.gov Identifier:
NCT00440310
First received: February 23, 2007
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Liver Metastases
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasm Recurrence, Local
Drug: Talaporfin sodium
Procedure: Percutaneous placement of device in liver metastases
Device: Interstitial light emitting diodes
Drug: FOLFOX4 OR FOLFIRI regimen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Light Sciences Oncology:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 184 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 184 weeks ] [ Designated as safety issue: No ]

Enrollment: 483
Study Start Date: February 2007
Study Completion Date: October 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Litx + Chemotherapy Drug: Talaporfin sodium
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Procedure: Percutaneous placement of device in liver metastases
Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Device: Interstitial light emitting diodes
200 J/cm per Light Source at 20 mW/cm light energy
Drug: FOLFOX4 OR FOLFIRI regimen
Standard care chemotherapy regimens
Active Comparator: Chemotherapy alone Drug: FOLFOX4 OR FOLFIRI regimen
Standard care chemotherapy regimens

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 bevacizimab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizimab 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440310

  Show 57 Study Locations
Sponsors and Collaborators
Light Sciences Oncology
Investigators
Study Director: Sy-Shi Wang, PhD Light Sciences Oncology
  More Information

No publications provided

Responsible Party: Light Sciences Oncology
ClinicalTrials.gov Identifier: NCT00440310     History of Changes
Other Study ID Numbers: LSO-OL006
Study First Received: February 23, 2007
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Croatia: Ministry of Health and Social Care
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Bosnia: Federal Ministry of Health
Latvia: State Agency of Medicines
Slovakia: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Sweden: Medical Products Agency
Austria: Federal Office for Safety in Health Care
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
India: Drugs Controller General of India

Keywords provided by Light Sciences Oncology:
Liver neoplasms
Liver metastases
MCRC
Litx™
LS11
Colorectal cancer with recurrent liver metastases

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasm Recurrence, Local
Recurrence
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Disease Attributes
Liver Diseases
Talaporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014