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

September 26, 2011 updated by: NovoCure Ltd.

An Open Label Pilot Study of NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • CCRC
      • Chur, Switzerland
        • Kantonspital Graubunden
      • Fribourg, Switzerland
        • Kantonspital Fribourg
      • Winterthur, Switzerland
        • Kantonspital Winterthur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Alimta
  • TTFields
  • Pemetrexed
  • Electric fields

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device related toxicity
Time Frame: until 2 months after treatment termination
until 2 months after treatment termination

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: Six months after recruitment of the last patient in the trial
Six months after recruitment of the last patient in the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovoCure Ltd.

Investigators

  • Principal Investigator: Miklos Pless, MD, Kantonspital Winterthur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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