2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC) (NVALT10)

Study Description

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Brief Summary:

The purpose of this study is to assess if the combination of erlotinib and chemotherapy (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types) is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).

Condition or disease	Intervention/treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: erlotinib plus docetaxel or pemetrexed; Drug: erlotinib	Phase 2

Detailed Description:

Open randomized multicenter phase II study in patiënts in need of 2nd line treatment for advanced/metastatic NSCLC. Efficacy and safety of monotherapy with erlotinib will be compared with combination therapy of erlotinib and chemotherapy. In recent studies it was established that pemetrexed activity is more pronounced in non-squamous NSCLC in comparison to squamous cell carcinoma. Therefore in patients with non-squamous carcinoma pemetrexed will be used. As in second line treatment of NSCLC docetaxel is registered also for usage in patients with squamous cell carcinoma, docetaxel will be used in patients with squamous histology.

Chemotherapy will be limited to 4 courses. Erlotinib will be continued until disease progression or unacceptable toxicity.

Erlotinib as monotherapy will be administered continuously. In combination with chemotherapy, erlotinib will be given from day 2-16 of every course of 3 weeks.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	230 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)
Study Start Date :	March 2009
Estimated Primary Completion Date :	June 2013
Estimated Study Completion Date :	June 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)	Drug: erlotinib plus docetaxel or pemetrexed; non-squamous carcinoma: pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16, every 21 days. Pemetrexed will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression. squamous carcinoma: Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days. Docetaxel will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression.; Other Names: Tarceva; Taxotere; Alimta
Active Comparator: 2; Erlotinib	Drug: erlotinib; erlotinib 150 mg/day continuously until disease progression; Other Name: Tarceva

Outcome Measures

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Primary Outcome Measures :

1. Imaging [ Time Frame: Every 6 weeks until disease progression ]
   Chest X ray, CT. Bone scan, brain scan (if clinically indicated) for Progression free survival Response rate Duration of response

Secondary Outcome Measures :

1. Safety [ Time Frame: Every 3 weeks during chemotherapy ]
   Haematology, chemistry, adverse events, physical examination

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
2. Complete recovery from prior chemotherapy side effects to < Grade 2.
3. At least one unidimensional measurable lesion meeting RECIST criteria.
4. ECOG PS 0-2.
5. Age > 18 years.

6. Adequate organ function, including:

   • Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
   • Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 1.5 x ULN AP, ALT, and AST <5 x ULN is acceptable if the liver has tumor involvement
   • Renal: calculated creatinin clearance > 40 ml/min based on the Cockcroft-Gault formula.
7. Estimated life expectancy >12 weeks.
8. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
9. Signed informed consent.
10. Patient compliance and geographical proximity that allow adequate follow up.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
4. Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
5. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
6. Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
7. Concomitant treatment with any other experimental drug under investigation.

Contacts and Locations

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Contacts

Contact: Joachim G. Aerts, MD PhD	+31 765953121	rsc@rsconsultancy.nl
Contact: Henk E. Codrington, MD	+31 702102076	rsc@rsconsultancy.nl

Locations

Netherlands
VU medisch centrum	Recruiting
Amsterdam, Netherlands
Contact: Smit ef.smit@vumc.nl
Principal Investigator: Egbert F. Smit, MD PhD
Rode Kruis Ziekenhuis	Recruiting
Beverwijk, Netherlands
Contact: Rikers mscrk@rkz.nl
Principal Investigator: C. H. Rikers, MD
Amphia Ziekenhuis	Recruiting
Breda, Netherlands
Contact: Aerts jaerts@amphia.nl
Principal Investigator: Joachim G. Aerts, MD PhD
Reinier de Graaf Gasthuis	Recruiting
Delft, Netherlands
Contact: Pannekoek pkoek@rdgg.nl
Principal Investigator: B. J. Pannekoek, MD
Jeroen Bosch Ziekenhuis	Recruiting
Den Bosch, Netherlands
Contact: Biesma b.biesma@jbz.nl
Principal Investigator: Bonne Biesma, MD PhD
Catharina-Ziekenhuis	Recruiting
Eindhoven, Netherlands
Contact: van den Borne ben.vd.borne@cze.nl
Principal Investigator: Ben E. van den Borne, MD PhD
Martini Ziekenhuis	Recruiting
Groningen, Netherlands
Contact: van Putten jwg.van.putten@mzh.nl
Principal Investigator: John W. van Putten, MD PhD
Kennemer Gasthuis	Recruiting
Haarlem, Netherlands
Contact: Weenink weenink@kg.nl
Principal Investigator: C. Weenink, MD PhD
Academisch Ziekenhuis Maastricht	Recruiting
Maastricht, Netherlands
Contact: Dingemans a.c.dingemans@lung.azm.nl
Principal Investigator: A. C. Dingemans, MD PhD
Universitair Medisch Centrum Sint Radboud	Recruiting
Nijmegen, Netherlands
Contact: van der Drift m.vanderdrift@ulc.umcn.nl
Principal Investigator: M. A. van der Drift, MD
Maasstad Ziekenhuis	Recruiting
Rotterdam, Netherlands
Contact: Slingerland slingerlandr@mcrz.nl
Principal Investigator: Rob Slingerland, MD
Sint Franciscus Gasthuis	Recruiting
Rotterdam, Netherlands
Contact: in 't Veen h.intveen@sfg.nl
Principal Investigator: J. C. in 't Veen, MD PhD
HagaZiekenhuis	Recruiting
The Hague, Netherlands
Contact: Codrington h.codrington@hagaziekenhuis.nl
Principal Investigator: Henk E. Codrington, MD
Isala Klinieken	Recruiting
Zwolle, Netherlands
Contact: Stigt j.a.stigt@isala.nl
Principal Investigator: Jos A. Stigt, MD

Sponsors and Collaborators

Dutch Society of Physicians for Pulmonology and Tuberculosis

Investigators

Study Director:	Joachim G. Aerts, MD PhD	Amphia Ziekenhuis, Breda, The Netherlands
Study Director:	Henk E. Coderington, MD	HagaZiekenhuis, The Hague, The Netherlands

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Dutch Society of Physicians for Pulmonology and Tuberculosis (NVALT) 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Aerts JG, Codrington H, Lankheet NA, Burgers S, Biesma B, Dingemans AM, Vincent AD, Dalesio O, Groen HJ, Smit EF; NVALT Study Group. A randomized phase II study comparing erlotinib versus erlotinib with alternating chemotherapy in relapsed non-small-cell lung cancer patients: the NVALT-10 study. Ann Oncol. 2013 Nov;24(11):2860-5. doi: 10.1093/annonc/mdt341. Epub 2013 Aug 28.

Responsible Party:	J.G.J.V. Aerts MD PhD, Dutch Society of Physicians for Pulmonology and Tuberculosis (NVALT)
ClinicalTrials.gov Identifier:	NCT00835471 History of Changes
Other Study ID Numbers:	NVALT10
First Posted:	February 3, 2009
Last Update Posted:	July 26, 2010
Last Verified:	July 2010

Keywords provided by Dutch Society of Physicians for Pulmonology and Tuberculosis:

Lung cancer; non-small-cell; erlotinib; chemotherapy

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Docetaxel	Erlotinib Hydrochloride; Pemetrexed; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Protein Kinase Inhibitors; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors