NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT00749346
First received: September 8, 2008
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

An open-label phase I-II trial will be performed in 42 patients with pretreated locally advanced non-small cell lung cancer. The trial is designed to estimate the efficacy and to determine safety of NovoTTF-100L treatment combined with Pemetrexed for advanced NSCLC patients. Patients will receive standard Pemetrexed therapy (at 500 mg/m2 iv q3w for 3 cycles) concomitant to NovoTTF-100L therapy (12 hours a day, daily until the end of all three cycles of Alimta). Repeat treatments with Alimta + NovoTTF-100L will be offered as long as the patient is stable or responding. If there is a in-field response with progression outside of the NovoTTF field, Pemetrexed is to be stopped and third line chemotherapy with Docetaxel is to be initiated (35 mg/m2 weekly, d1, 8, 15, q 28 d).


Condition Intervention Phase
Non-small Cell Lung Cancer
NSCLC
Device: NovoTTF-100L
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study of NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Device related toxicity [ Time Frame: until 2 months after treatment termination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Six months after recruitment of the last patient in the trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treatment with concomitant Alimta and NovoTTF-100L
Device: NovoTTF-100L
TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing
Other Names:
  • TTFields
  • Pemetrexed
  • Alimta
  • Electric fields

Detailed Description:

The trial will be conducted in two stages. Fourteen patients will be recruited to a phase I stage of the trial. After all 14 patients have received 3 courses of Alimta (9 weeks of NovoTTF-100L treatment), these patients will be analyzed for toxicity. If the incidence of device related serious adverse events is < 20%, the trial will continue to the second stage where 42 patients will be assessed for safety and efficacy as part of a phase II study (including the first 14 patients in the phase I study).

Efficacy will be assessed based on local disease control in the lungs and liver, time to systemic disease progression, and overall survival. Patients will be followed for at least 6 months after the last course of NovoTTF-100L is applied to assess survival.

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IV or IIIB with malignant pleural effusion, also locally advanced NSCLC not otherwise amenable to local treatment (surgery or radiotherapy)
  • One line of prior chemotherapy
  • Measurable disease
  • Greater or equal to 18 years
  • Life expectancy of at least 12 weeks
  • ECOG performance status 0-2
  • Laboratory requirements at entry:
  • Blood cell counts:
  • Absolute neutrophils ≥ 1.0 x 109/L
  • Platelets ≥100 x 109/L
  • Hemoglobin ≥ 10 g/dl
  • Renal function:
  • Creatinine clearance ≥ 45 mL/min
  • Hepatic functions:
  • ASAT and ALAT ≤ 3 x UNL
  • Alkaline phosphatase ≤ 5 x UNL
  • Signed informed consent prior to start protocol specific requirements
  • Pregnancy test (β-HCG) must be negative (needed only for women of childbearing potential).

Exclusion Criteria:

  • Known brain metastases or meningeal carcinomatosis
  • Other serious concomitant illness of medical conditions:
  • Congestive heart failure or angina pectoris except if it is medically controlled.
  • Previous history of myocardial infarction within 1 year from study entry.
  • Uncontrolled hypertension or arrhythmias
  • Implanted pacemaker, defibrillator or deep brain stimulation device
  • History of significant neurologic or psychiatric disorders including dementia or seizures
  • Active infection requiring iv antibiotics
  • Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy
  • Concurrent treatment with other experimental drugs
  • Participation in clinical trials with other experimental agents within 30 days of study entry
  • Psychological, familial, sociological or geographical conditions which don't permit medical follow-up and compliance with the study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749346

Locations
Switzerland
CCRC
Basel, Switzerland
Kantonspital Graubunden
Chur, Switzerland
Kantonspital Fribourg
Fribourg, Switzerland
Kantonspital Winterthur
Winterthur, Switzerland
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Miklos Pless, MD Kantonspital Winterthur
  More Information

Additional Information:
Publications:
Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT00749346     History of Changes
Other Study ID Numbers: EF-15
Study First Received: September 8, 2008
Last Updated: September 26, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by NovoCure Ltd.:
TTFields
NSCLC
Alimta
Pemetrexed

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
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 April 17, 2014