2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00835471
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2009-03-31
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
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
Erlotinib
erlotinib
erlotinib 150 mg/day continuously until disease progression
Interventions
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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.
erlotinib
erlotinib 150 mg/day continuously until disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Dutch Society of Physicians for Pulmonology and Tuberculosis
OTHER
Responsible Party
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Principal Investigators
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Joachim G. Aerts, MD PhD
Role: STUDY_DIRECTOR
Amphia Ziekenhuis, Breda, The Netherlands
Henk E. Coderington, MD
Role: STUDY_DIRECTOR
HagaZiekenhuis, The Hague, The Netherlands
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
VU medisch centrum
Amsterdam, , Netherlands
Rode Kruis Ziekenhuis
Beverwijk, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Catharina-Ziekenhuis
Eindhoven, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Kennemer Gasthuis
Haarlem, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Universitair Medisch Centrum Sint Radboud
Nijmegen, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Sint Franciscus Gasthuis
Rotterdam, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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References
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De Ruysscher D, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder J, Haitjema T, Ubbels F, Lagerwaard F, El Sharouni SY, Stigt JA, Smit E, van Tinteren H, van der Noort V, Groen HJM. Prophylactic Cranial Irradiation Versus Observation in Radically Treated Stage III Non-Small-Cell Lung Cancer: A Randomized Phase III NVALT-11/DLCRG-02 Study. J Clin Oncol. 2018 Aug 10;36(23):2366-2377. doi: 10.1200/JCO.2017.77.5817. Epub 2018 May 22.
Witlox WJA, Ramaekers BLT, Groen HJM, Dingemans AM, Praag J, Belderbos J, van der Noort V, van Tinteren H, Joore MA, De Ruysscher DKM. Factors determining the effect of prophylactic cranial irradiation (PCI) in patients with stage-III nonsmall cell lung cancer: exploratory subgroup analyses of the NVALT-11/DLCRG-02 phase-III study. Acta Oncol. 2019 Oct;58(10):1528-1531. doi: 10.1080/0284186X.2019.1629016. Epub 2019 Jul 1. No abstract available.
Witlox WJA, Ramaekers BLT, Joore MA, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder G, Haitjema T, Ubbels JF, Lagerwaard J, El Sharouni SY, Stigt JA, Smit EF, van Tinteren H, van der Noort V, Groen HJM, De Ruysscher DKM. Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiother Oncol. 2020 Mar;144:65-71. doi: 10.1016/j.radonc.2019.10.016. Epub 2019 Nov 14.
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.
Related Links
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Dutch Society of Physicians for Pulmonology and Tuberculosis (NVALT)
Other Identifiers
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NVALT10
Identifier Type: -
Identifier Source: org_study_id
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