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

Primary Purpose

Non-small Cell Lung Cancer, NSCLC

Status

Completed

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

NovoTTF-100L

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring TTFields, NSCLC, Alimta, Pemetrexed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CCRC
Kantonspital Graubunden
Kantonspital Fribourg
Kantonspital Winterthur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Treatment with concomitant Alimta and NovoTTF-100L

Outcomes

Primary Outcome Measures

Device related toxicity

Secondary Outcome Measures

Time to progression

Full Information

NCT ID

NCT00749346

First Posted

September 8, 2008

Last Updated

September 26, 2011

Sponsor

NovoCure Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00749346

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NovoCure Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, NSCLC

Keywords

TTFields, NSCLC, Alimta, Pemetrexed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Treatment with concomitant Alimta and NovoTTF-100L

Intervention Type

Device

Intervention Name(s)

NovoTTF-100L

Other Intervention Name(s)

TTFields, Pemetrexed, Alimta, Electric fields

Intervention Description

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

Primary Outcome Measure Information:

Title

Device related toxicity

Time Frame

until 2 months after treatment termination

Secondary Outcome Measure Information:

Title

Time to progression

Time Frame

Six months after recruitment of the last patient in the trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miklos Pless, MD

Organizational Affiliation

Kantonspital Winterthur

Official's Role

Principal Investigator

Facility Information:

Facility Name

CCRC

City

Basel

Country

Switzerland

Facility Name

Kantonspital Graubunden

City

Chur

Country

Switzerland

Facility Name

Kantonspital Fribourg

City

Fribourg

Country

Switzerland

Facility Name

Kantonspital Winterthur

City

Winterthur

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

15126372

Citation

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.

Results Reference

background

PubMed Identifier

17551011

Citation

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.

Results Reference

background

PubMed Identifier

18596382

Citation

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.

Results Reference

background

Links:

URL

http://www.novocuretrial.com

Description

NovoCure educational website for the the EF-11 Recurrent GBM study using TTFields - includes scientific background on the principals of operation of the TTFields technology

Learn more about this trial

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

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