Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Dutch Society of Physicians for Pulmonology and Tuberculosis |
---|---|
Information provided by: | Dutch Society of Physicians for Pulmonology and Tuberculosis |
ClinicalTrials.gov Identifier: | NCT00835471 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-Erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study) |
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 |
---|---|
1: Experimental
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. |
2: Active Comparator
Erlotinib
|
Drug: erlotinib
erlotinib 150 mg/day continuously until disease progression
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function, including:
Exclusion Criteria:
Contact: Joachim G. Aerts, MD PhD | +31 765953121 | rsc@rsconsultancy.nl |
Contact: Henk E. Codrington, MD | +31 702102076 | rsc@rsconsultancy.nl |
Netherlands | |
HagaZiekenhuis | |
The Hague, Netherlands | |
Amphia Ziekenhuis | |
Breda, Netherlands | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands | |
Catharina-Ziekenhuis | |
Eindhoven, Netherlands | |
Isala Klinieken | |
Zwolle, Netherlands | |
Jeroen Bosch Ziekenhuis | |
Den Bosch, Netherlands | |
Kennemer Gasthuis | |
Haarlem, Netherlands | |
VU medisch centrum | |
Amsterdam, Netherlands | |
Martini Ziekenhuis | |
Groningen, Netherlands | |
Reinier de Graaf Gasthuis | |
Delft, Netherlands | |
Rode Kruis Ziekenhuis | |
Beverwijk, Netherlands | |
Sint Franciscus Gasthuis | |
Rotterdam, Netherlands | |
Tergooiziekenhuizen | |
Hilversum, Netherlands | |
Universitair Medisch Centrum Sint Radboud | |
Nijmegen, Netherlands | |
Maasstad Ziekenhuis | |
Rotterdam, Netherlands |
Study Director: | Joachim G. Aerts, MD PhD | Amphia Ziekenhuis, Breda, The Netherlands |
Study Director: | Henk E. Coderington, MD | HagaZiekenhuis, The Hague, The Netherlands |
Responsible Party: | Dutch Society of Physicians for Pulmonology and Tuberculosis (NVALT) ( J.G.J.V. Aerts MD PhD ) |
Study ID Numbers: | NVALT10 |
Study First Received: | February 2, 2009 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00835471 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Lung cancer non-small-cell erlotinib chemotherapy |
Antimetabolites Thoracic Neoplasms Erlotinib Folic Acid Antagonists Protein Kinase Inhibitors Carcinoma Docetaxel Pemetrexed |
Folic Acid Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Erlotinib Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Docetaxel Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |