Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma
NCT ID: NCT02775006
Last Updated: 2019-04-30
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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TERMINATED
PHASE3
45 participants
INTERVENTIONAL
2016-10-14
2019-04-30
Brief Summary
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Detailed Description
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As pemetrexed is standard first line treatment, the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment. Also the question has to be answered whether the combination outperforms monotherapy treatments.
After stratification for ECOG-performance status (0-1), response to prior treatment (CR, PR, SD versus PD), treatment free interval after platinum based therapy (\<6 months versus \>6 months) and maintenance, patients will be centrally randomized to receive either docetaxel (arm A) or docetaxel plus erlotinib (arm B).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel
Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related
Docetaxel
75mg/m2
Docetaxel plus erlotinib
Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related.
Docetaxel
75mg/m2
Erlotinib
150mg/day
Interventions
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Docetaxel
75mg/m2
Erlotinib
150mg/day
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 unidimensionally measurable lesion meeting RECIST criteria.
4. ECOG PS 0-1.
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 (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP, ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.
* Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault formula.
7. 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.
8. Signed informed consent.
9. Patient compliance and geographical proximity that allow adequate follow up.
10. Patients who have undergone cranial irradiation for brain metastases more than 4 weeks before inclusion in our protocol, provided that they are clinically fit to undergo second line treatment
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 at least 4 weeks before enrollment and has been off corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at least 4 weeks prior to enrollment is accepted.
4. Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with an EGFR-TKI or docetaxel within 6 months prior to enrollment.
5. Inability or unwillingness to take dexamethasone.
6. Concomitant treatment with any other experimental drug under investigation.
7. Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy
18 Years
ALL
No
Sponsors
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Dutch Society of Physicians for Pulmonology and Tuberculosis
OTHER
The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Joachim G Aerts, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dutch Society of Physicians for Pulmonology and Tuberculosis
Locations
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VUmc Medical Center
Amsterdam, North Holland, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Gelre Ziekenhuis
Apeldoorn, , Netherlands
Amphia Hospital
Breda, , Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Spaarne Gasthuis
Hoofddorp, , Netherlands
MCL
Leeuwarden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Laurentius Hospital
Roermond, , Netherlands
St. Fransicus Gasthuis
Rotterdam, , Netherlands
Ikazia
Rotterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haga
The Hague, , Netherlands
Medical Center Haaglanden
The Hague, , Netherlands
St. Antonius ziekenhuis
Utrecht, , Netherlands
VieCuri Medisch Centrum voor Noord-Limburg
Venlo, , Netherlands
Countries
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Other Identifiers
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NVALT 18
Identifier Type: -
Identifier Source: org_study_id
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