Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by NCIC Clinical Trials Group
Sponsor:
Collaborator:
Oncolytics Biotech
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01708993
First received: October 15, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to find out if giving reolysin in combination with docetaxel or pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Pemetrexed and Reolysin (and safety run-in)
Drug: Pemetrexed
Drug: Docetaxel and Reolysin
Drug: Docetaxel
Phase 2

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 Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Evaluation of the effect of reolysin in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic NSCLC. Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee


Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    To determine the tolerability and toxicity of reolysin and standard salvage chemotherapy when given in combination.

  • Response rates [ Time Frame: 30 months ] [ Designated as safety issue: No ]

    To investigate additional potential measures of efficacy including:

    • Progression rates at 3 months
    • Objective response rate
    • Overall survival (OS)

  • Explore potential molecular factors predictive of response [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Exploration of potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples.


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A: Pemetrexed and Reolysin (and safety run-in) Drug: Pemetrexed and Reolysin (and safety run-in)
Pemetrexed: 500 mg/m², IV (10 min) - Day 1 every 3 weeks Reolysin: 4.5 x 10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
Active Comparator: Arm B: Pemetrexed Drug: Pemetrexed
Pemetrexed: 500 mg/m² IV (10 min) - Day 1 every 3 weeks
Active Comparator: Arm C: Docetaxel and Reolysin (and safety run-in) Drug: Docetaxel and Reolysin
Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks Reolysin: 4.5x10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
Active Comparator: Arm D: Docetaxel Drug: Docetaxel
Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks

Detailed Description:

Reolysin is a virus which has been shown to target and destroy cancer cells in laboratory tests. Reolysin has been studied in over 360 cancer patients to find safe doses that can be given and has also undergone testing in combination with docetaxel.

Docetaxel and pemetrexed have anticancer activity in certain cancers including lung and they have been approved by Health Canada for the treatment of patients with advanced or metastatic non-small cell lung cancer.

Researchers doing this study also want to evaluate the side effects of reolysin when given together with docetaxel or pemetrexed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC). As treatment arm is assigned based on histology subtype, it must be feasible to subtype into squamous or other.
  • All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available for translational studies and must have provided informed consent for the release of the block as well as for blood samples for correlative studies.
  • Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows:

    • Chest X-ray ≥ 20 mm
    • CT/MRI scan (with slice thickness of < 5 mm) ≥ 10 mm --> longest diameter
    • Physical exam (using calipers) ≥ 10 mm
    • Lymph nodes by CT scan ≥ 15 mm --> measured in short axis All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).
  • Patients must have advanced and or metastatic disease, for which no curative therapy exists and for which systemic therapy is indicated.
  • ECOG performance of 0 or 1.
  • Age ≥ 18 years.

Surgery: Previous major surgery is permitted provided that it has been at least 14 days prior to patient randomization and that wound healing has occurred.

Chemotherapy: Patients must have received one regimen of palliative first line chemotherapy (must be platinum containing combination unless patient's age > 70 years) which may not have contained docetaxel. Patients who have had concurrent platinum based chemoradiotherapy for stage three disease and have relapsed within one year of treatment, or patients who have had platinum based adjuvant chemotherapy after complete surgical resection and have relapsed within one year of treatment, may be considered to have had one prior platinum containing regimen.

Prior paclitaxel is permissible. Patients who have had prior pemetrexed for first line therapy will be randomized to Treatment Arm C or D (docetaxel ± reolysin). Prior maintenance therapy with pemetrexed is not permitted. Prior adjuvant chemotherapy is permissible providing completed at least 1 year prior to relapse/recurrence of disease and the patient has received one regimen of palliative first line chemotherapy as described above.

Other Therapy: Patients may have received other therapies including immunotherapy, or with signal transduction inhibitors, including EGFR inhibitors.

Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, non-myelosuppressive radiotherapy.

  • Laboratory Requirements (must be done within 7 days prior to randomization)

    • Hematology:
    • Neutrophils ≥ 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Biochemistry:
    • Serum creatinine ≤ 1.5 x ULN (For patients enrolled to a pemetrexed arm, the creatinine clearance must also be >45 ml/min)
    • Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to conditions such as Gilbert's disease)
    • ALT and AST ≤ 1.5 x ULN (≤ 3x ULN is permitted in the presence of known liver metastases)
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.

Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.

  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization.

Exclusion Criteria:

  • Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for > 3 years.
  • Patients who are on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
  • Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
  • Patients with significant cardiac (including uncontrolled hypertension) or pulmonary disease, or active CNS disease or infection.
  • Patients with a known hypersensitivity to the study drug(s) or their components.
  • Patients with untreated brain metastases, untreated spinal cord compression or meningeal metastases are not eligible (CT scans are not required to rule this out unless there is a clinical suspicion of CNS disease). Patients with treated brain metastases who have radiologic evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
  • Patients who have neuropathy ≥ grade 2 (patients planned for docetaxel Arms C and D only).
  • Women must be post-menopausal, surgically sterile or use two reliable forms of contraception while on study and for 6 months after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration/randomization and must not be lactating. Men must be surgically sterile or use a barrier method of contraception.
  • Concurrent treatment with other investigational drugs or anti-cancer therapy.
  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: NCT01708993

Contacts
Contact: Penelope Bradbury 613-533-6430 pbradbury@ctg.queensu.ca
Contact: Lesley Seymour 613-533-6430 lseymour@ctg.queensu.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Donald G. Morris    403 521-3347      
Canada, British Columbia
BCCA - Abbotsford Centre Recruiting
Abbotsford, British Columbia, Canada, V2S 0C2
Contact: Bruce D. Keith    604 851-4741 ext 647488      
BCCA - Fraser Valley Cancer Centre Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Thuan Do    604 930-4064      
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Nevin Murray    604 877-6000 ext 2707      
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: John Goffin    905 387-9495      
Cancer Centre of Southeastern Ontario at Kingston Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Richard W. Gregg    613 549-6666 ext 4509      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Sara Kuruvilla    519 685-8640      
Lakeridge Health Oshawa Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Rafal Wierzbicki    905 576-8711 ext 4044      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Garth Nicholas    613 737-7700 ext 70178      
Univ. Health Network-Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Geoffrey Liu    416 946-4501 ext 3428      
Canada, Quebec
McGill University - Dept. Oncology Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Victor Cohen    514 340-8222 ext 5527      
CHUM - Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Moustapha Tehfe    514 890-8444      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Vamsee Torri    306 766-2691      
Sponsors and Collaborators
NCIC Clinical Trials Group
Oncolytics Biotech
Investigators
Study Chair: Donald G Morris Tom Baker Cancer Centre, Calgary Alberta Canada
  More Information

No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01708993     History of Changes
Other Study ID Numbers: I211
Study First Received: October 15, 2012
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 23, 2014