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

NCT00749346 | Completed Phase 1

• 1 other identifier: EF-15
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Non-small Cell Lung Cancer; NSCLC

Keywords

TTFields; NSCLC; Alimta; Pemetrexed

Outcome Measures

Primary Outcomes (1)

• Device related toxicity

  until 2 months after treatment termination

Secondary Outcomes (1)

• Time to progression

  Six months after recruitment of the last patient in the trial

Study Arms (1)

A

EXPERIMENTAL

Treatment with concomitant Alimta and NovoTTF-100L

Device: NovoTTF-100L

Interventions

NovoTTF-100L DEVICE

TTFields treatment 12h/d for the duration of the study (until progression)concomitant to standard Alimta dosing

Also known as: TTFields, Pemetrexed, Alimta, Electric fields

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• NovoCure Ltd.: lead

Study Sites (4)

CCRC

Basel, Switzerland

Location

Kantonspital Graubunden

Chur, Switzerland

Location

Kantonspital Fribourg

Fribourg, Switzerland

Location

Kantonspital Winterthur

Winterthur, Switzerland

Location

Related Publications (3)

• Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

  PMID: 15126372 BACKGROUND

• Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

  PMID: 17551011 BACKGROUND

• Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

  PMID: 18596382 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Miklos Pless, MD

  Kantonspital Winterthur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

CH (4)