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An Open-Label, Randomized, Parallel Group Study of Patients Treated With Paclitaxel With Standard Dosing Versus Pharmacokinetic Guided Dose Adjustment in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
75 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

An Open-Label, Randomized, Parallel Group Study of Patients Treated With Paclitaxel With Standard Dosing Versus Pharmacokinetic Guided Dose Adjustment in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Capable of understanding the protocol requirements and risks, and providing written
informed consent.

- Patients with histologically confirmed NSCLC (stage IIIB-IV).

- 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.

- At least one bidimensionally measurable lesion according to RECIST 1.1.

- ECOG Performance Status (ECOG-PS) status ≤ 2.

- Female or male patients of 18 to 75 years of age at randomization

- 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).

- An absolute neutrophil count >1,500 cells/ mm3 (= 1.5 G/l).

- Platelet count > 100,000/mm3.

- Total bilirubin ≤ 2 x upper limit of normal.

- AST and ALT ≤ 2.5 x upper limit of normal, or ≤ 5 x upper limit of normal in case of
liver metastases.

- Creatinine clearance (according to the Cockcroft-Gault formula) ≥30ml/min. For
patients planned to receive Cisplatin: Creatinine clearance ≥60ml/min.

- 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.

Exclusion Criteria:

- 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.

- A history of hypersensitivity reactions to drugs formulated in polyoxyethylated
castor oil.

- Having received prior treatment with paclitaxel or cisplatin or carboplatin (other
drugs/drug combinations are allowed).

- Concomitant treatment with any targeted drug (licensed or experimental) like
bevacizumab or cetuximab.

- Any condition / concomitant disease not allowing chemotherapy with paclitaxel, the
platinum compound (carboplatin or cisplatin) or required premedication for the
treatment regimen.

- Pregnant/nursing women.

- Individuals known to be seropositive for human immunodeficiency virus, hepatitis C
virus, hepatitis B surface antigen or syphilis.

- Treatment with cytotoxic or biologic agents or any experimental drug within the 4
weeks prior to beginning treatment on this study.

- 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.

- Medical or psychological conditions that would not permit the patient to complete the
study or sign informed consent.

- Preexisting neuropathy > grade I NCI-CTC.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grad 4 Neutropenia

Outcome Description:

The rate of grade 4 Neutropenia during the second treatment cycle between the conventional Paclitaxel dosing arm and pharmacokinetically driven Paclitaxel dosing arm is compared. At the same time progression free survival and overall survival must not be affected.

Outcome Time Frame:

up to 6 weeks on treatment

Safety Issue:


Principal Investigator

Markus Joerger, MD PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Central European Society for Anticancer Drug Research


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2011

Completion Date:

August 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung