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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Dutch Society of Physicians for Pulmonology and Tuberculosis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dutch Society of Physicians for Pulmonology and Tuberculosis
ClinicalTrials.gov Identifier:
NCT00835471
First received: February 2, 2009
Last updated: July 23, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: erlotinib plus docetaxel or pemetrexed
Drug: erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Dutch Society of Physicians for Pulmonology and Tuberculosis:

Primary Outcome Measures:
  • Imaging [ Time Frame: Every 6 weeks until disease progression ] [ Designated as safety issue: No ]
    Chest X ray, CT. Bone scan, brain scan (if clinically indicated) for Progression free survival Response rate Duration of response


Secondary Outcome Measures:
  • Safety [ Time Frame: Every 3 weeks during chemotherapy ] [ Designated as safety issue: Yes ]
    Haematology, chemistry, adverse events, physical examination


Estimated Enrollment: 230
Study Start Date: March 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835471

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

Additional Information:
No publications provided by Dutch Society of Physicians for Pulmonology and Tuberculosis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: February 2, 2009
Last Updated: July 23, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Dutch Society of Physicians for Pulmonology and Tuberculosis:
Lung cancer
non-small-cell
erlotinib
chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014