An Open-Label, Randomized, Parallel Group Study of Patients Treated with Paclitaxel with Standard Dosing versus Pharmacokinetic Guided Dose Adjustment in Patients with Advanced NSCLC

An Open-Label, Randomized, Parallel Group Study of Patients Treated with Paclitaxel with Standard Dosing versus Pharmacokinetic Guided Dose Adjustment in Patients with Advanced NSCLC - CEPAC-TDM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023688-16-DE

Enrollment

366

Registered

2011-01-12

Start date

2011-01-27

Completion date

Unknown

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III-IV Non Small Cell Lung Cancer (NSCLC) MedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864

Interventions

Trade Name: Various marketing authorization holder. Cesar has no influence which Paclitaxel is used in course of this trial Product Name: Paclitaxel Pharmaceutical Form: Concentrate for solution for i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Capable of understanding the protocol requirements and risks, and providing written informed consent. (2)Patients with histologically confirmed NSCLC (stage IIIB-IV). (3)Patients considered for first-line palliative chemotherapy with paclitaxel in combination with either cisplatin or carboplatin. Patients having received prior adjuvant non taxane-containing adjuvant chemotherapy are eligible. (4)At least one bidimensionally measurable lesion according to RECIST 1.1. (5)ECOG Performance Status (ECOG-PS) status = 2. (6)Female or male patients of 18 to 75 years of age at randomization (7)Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods (condom). (8)An absolute neutrophil count >1,500 cells/ mm3 (= 1.5 G/l). (9)Platelet count > 100,000/mm3. (10)Total bilirubin = 2 x upper limit of normal. (11)AST and ALT = 2.5 x upper limit of normal, or = 5 x upper limit of normal in case of liver metastases. (12)Creatinine clearance (according to the Cockroft-Gault formula) =30ml/min. For patients planned to receive Cisplatin: Creatinine clearance =60ml/min. (13)Patients suffering from asymptomatic brain metastases can be enrolled in case corticosteroid therapy is not indicated. Prior irradiation must be completed at least 4 weeks prior to first cycle of treatment. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: (1)Serious concomitant systemic disorders (e.g., active infection, severe heart disease, uncontrolled hypertension or diabetes mellitus) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study. (2)A history of hypersensitivity reactions to drugs formulated in polyoxyethylated castor oil. (3)Having received prior treatment with paclitaxel or cisplatin or carboplatin (other drugs/drug combinations are allowed). (4)Concomitant treatment with any targeted drug (licensed or experimental) like bevacizumab or cetuximab. (5)Any condition / concomitant disease not allowing chemotherapy with paclitaxel, the platinum compound (carboplatin or cisplatin) or required premedication for the treatment regimen. (6)Pregnant/nursing women. (7)Individuals known to be seropositive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen or syphilis. (8)Treatment with cytotoxic or biologic agents or any experimental drug within the 4 weeks prior to beginning treatment on this study. (9)Secondary malignancy within the last five years, with the exception of adequately treated carcinoma-in-situ of the uterine cervix, basal-cell carcinoma of the skin and pTa or pTis urothelial cancer. (10)Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent. (11)Preexisting neuropathy > grade I NCI-CTC.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the CEPAC-TDM study is to apply individualized paclitaxel dosing in patients with advanced NSCLC, as defined in Section 1.4. By applying the prespecified dosing algorithm, grade 4 neutropenia is predicted to be reduced from 15% with conventional dosing (i.e. paclitaxel 200 mg/m2 in combination with carboplatin or cisplatin at the predefined dose, given every three weeks) (Arm A) to 4% with individualized paclitaxel dosing (in combination with carboplatin or cisplatin at the predefined dose, given every three weeks) (Arm B) during the second treatment cycle. At the same time, progression-free survival (PFS) and overall survival (OS) must not be affected by individualized paclitaxel dosing. ;Secondary Objective: • Objective tumor response according to RECIST version 1.1 • Progression free survival (PFS) • Overall survival (OS) • Overall neutropenia ( i.e. during total chemotherapy duration) assessed from clinical hematology data and by model-based estimations of individual neutrophil curves • Hematological (leucocytopenia, anemia, thrombocytopenia) and non-hematological toxicites (e.g. neurological, musculosceletal and gastrointestinal adverse events) • Cumulative dose and dose intensity of paclitaxel and platinum drug • Incidence of changes from cisplatin to carboplatin and reasons thereof • Overall rate of febrile neutropenia and hospitalization due to chemotherapy-associated adverse events • Health economic analysis ;Primary end point(s): Frequency of Grade 4 Neutropenia compared between the two treatment arms during the second treatment cycle.;Timepoint(s) of evaluation of this end point: Database lock	—

Measure

Time frame

Main Objective: The primary objective of the CEPAC-TDM study is to apply individualized paclitaxel dosing in patients with advanced NSCLC, as defined in Section 1.4. By applying the prespecified dosing algorithm, grade 4 neutropenia is predicted to be reduced from 15% with conventional dosing (i.e. paclitaxel 200 mg/m2 in combination with carboplatin or cisplatin at the predefined dose, given every three weeks) (Arm A) to 4% with individualized paclitaxel dosing (in combination with carboplatin or cisplatin at the predefined dose, given every three weeks) (Arm B) during the second treatment cycle. At the same time, progression-free survival (PFS) and overall survival (OS) must not be affected by individualized paclitaxel dosing. ;Secondary Objective: • Objective tumor response according to RECIST version 1.1 • Progression free survival (PFS) • Overall survival (OS) • Overall neutropenia ( i.e. during total chemotherapy duration) assessed from clinical hematology data and by model-based estimations of individual neutrophil curves • Hematological (leucocytopenia, anemia, thrombocytopenia) and non-hematological toxicites (e.g. neurological, musculosceletal and gastrointestinal adverse events) • Cumulative dose and dose intensity of paclitaxel and platinum drug • Incidence of changes from cisplatin to carboplatin and reasons thereof • Overall rate of febrile neutropenia and hospitalization due to chemotherapy-associated adverse events • Health economic analysis ;Primary end point(s): Frequency of Grade 4 Neutropenia compared between the two treatment arms during the second treatment cycle.;Timepoint(s) of evaluation of this end point: Database lock

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Secondary

Measure	Time frame
Secondary end point(s): • Objective tumor response according to RECIST version 1.1 • Progression free survival (PFS) • Overall survival (OS) • Overall neutropenia ( i.e. during total chemotherapy duration) assessed from clinical hematology data and by model-based estimations of individual neutrophil curves • Hematological (leucocytopenia, anemia, thrombocytopenia) and non-hematological toxicites (e.g. neurological, musculosceletal and gastrointestinal adverse events) • Cumulative dose and dose intensity of paclitaxel and platinum drug • Incidence of changes from cisplatin to carboplatin and reasons thereof • Overall rate of febrile neutropenia and hospitalization due to chemotherapy-associated adverse events • Health economic analysis ;Timepoint(s) of evaluation of this end point: Database lock	—

Measure

Time frame

Secondary end point(s): • Objective tumor response according to RECIST version 1.1 • Progression free survival (PFS) • Overall survival (OS) • Overall neutropenia ( i.e. during total chemotherapy duration) assessed from clinical hematology data and by model-based estimations of individual neutrophil curves • Hematological (leucocytopenia, anemia, thrombocytopenia) and non-hematological toxicites (e.g. neurological, musculosceletal and gastrointestinal adverse events) • Cumulative dose and dose intensity of paclitaxel and platinum drug • Incidence of changes from cisplatin to carboplatin and reasons thereof • Overall rate of febrile neutropenia and hospitalization due to chemotherapy-associated adverse events • Health economic analysis ;Timepoint(s) of evaluation of this end point: Database lock

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Countries

Germany

Contacts

Public ContactClinical trials information

CESAR

00431522309312

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026