Trial record 1 of 1 for:    NCT00835471
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2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC) (NVALT10)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00835471
Recruitment Status : Unknown
Verified July 2010 by Dutch Society of Physicians for Pulmonology and Tuberculosis.
Recruitment status was:  Recruiting
First Posted : February 3, 2009
Last Update Posted : July 26, 2010
Information provided by:
Dutch Society of Physicians for Pulmonology and Tuberculosis

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 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

Resource links provided by the National Library of Medicine

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
Drug: erlotinib
erlotinib 150 mg/day continuously until disease progression
Other Name: Tarceva

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

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00835471

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

VU medisch centrum Recruiting
Amsterdam, Netherlands
Contact: Smit   
Principal Investigator: Egbert F. Smit, MD PhD         
Rode Kruis Ziekenhuis Recruiting
Beverwijk, Netherlands
Contact: Rikers   
Principal Investigator: C. H. Rikers, MD         
Amphia Ziekenhuis Recruiting
Breda, Netherlands
Contact: Aerts   
Principal Investigator: Joachim G. Aerts, MD PhD         
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands
Contact: Pannekoek   
Principal Investigator: B. J. Pannekoek, MD         
Jeroen Bosch Ziekenhuis Recruiting
Den Bosch, Netherlands
Contact: Biesma   
Principal Investigator: Bonne Biesma, MD PhD         
Catharina-Ziekenhuis Recruiting
Eindhoven, Netherlands
Contact: van den Borne   
Principal Investigator: Ben E. van den Borne, MD PhD         
Martini Ziekenhuis Recruiting
Groningen, Netherlands
Contact: van Putten   
Principal Investigator: John W. van Putten, MD PhD         
Kennemer Gasthuis Recruiting
Haarlem, Netherlands
Contact: Weenink   
Principal Investigator: C. Weenink, MD PhD         
Academisch Ziekenhuis Maastricht Recruiting
Maastricht, Netherlands
Contact: Dingemans   
Principal Investigator: A. C. Dingemans, MD PhD         
Universitair Medisch Centrum Sint Radboud Recruiting
Nijmegen, Netherlands
Contact: van der Drift   
Principal Investigator: M. A. van der Drift, MD         
Maasstad Ziekenhuis Recruiting
Rotterdam, Netherlands
Contact: Slingerland   
Principal Investigator: Rob Slingerland, MD         
Sint Franciscus Gasthuis Recruiting
Rotterdam, Netherlands
Contact: in 't Veen   
Principal Investigator: J. C. in 't Veen, MD PhD         
HagaZiekenhuis Recruiting
The Hague, Netherlands
Contact: Codrington   
Principal Investigator: Henk E. Codrington, MD         
Isala Klinieken Recruiting
Zwolle, Netherlands
Contact: Stigt   
Principal Investigator: Jos A. Stigt, MD         
Sponsors and Collaborators
Dutch Society of Physicians for Pulmonology and Tuberculosis
Study Director: Joachim G. Aerts, MD PhD Amphia Ziekenhuis, Breda, The Netherlands
Study Director: Henk E. Coderington, MD HagaZiekenhuis, The Hague, The Netherlands

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: J.G.J.V. Aerts MD PhD, Dutch Society of Physicians for Pulmonology and Tuberculosis (NVALT) Identifier: NCT00835471     History of Changes
Other Study ID Numbers: NVALT10
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
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