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
Recruitment status was Recruiting
Sponsor:
Dutch Society of Physicians for Pulmonology and Tuberculosis
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
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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:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Docetaxel
Pemetrexed
Pemetrexed disodium
Erlotinib hydrochloride
Erlotinib
U.S. FDA Resources
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:
|
|
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Complete recovery from prior chemotherapy side effects to < Grade 2.
- At least one unidimensional measurable lesion meeting RECIST criteria.
- ECOG PS 0-2.
- Age > 18 years.
-
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.
- Estimated life expectancy >12 weeks.
- 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.
- Signed informed consent.
- Patient compliance and geographical proximity that allow adequate follow up.
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
- 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.
- Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
- 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).
- Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
- 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
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:
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, 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 |
ClinicalTrials.gov processed this record on September 23, 2016