Know Cancer

forgot password

Phase II Trial of Weekly Docetaxel and Four Weekly Carboplatin Combination in the First-line Treatment of Advanced Non-small Cell Lung Cancer

Phase 2
75 Years
Not Enrolling
Lung Neoplasms

Thank you

Trial Information

Phase II Trial of Weekly Docetaxel and Four Weekly Carboplatin Combination in the First-line Treatment of Advanced Non-small Cell Lung Cancer

Inclusion Criteria:

- Histologically/cytologically confirmed inoperable locally advanced or metastatic
non-small cell lung cancer

- ECOG Performance Status is 0-2

- At least one measurable lesion in two dimensions by means of CT scan

- No brain metastases

- No prior chemotherapy for this malignancy,

- Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a
platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as
defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours
urine ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum
normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 2.5 x maximum
normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a
bone metastasis)

Exclusion Criteria:

- Concomitant use of another anti-cancer therapy

- Chemotherapy, radiotherapy or curative surgery

- Evidence of intracerebral metastasis

- Unstable medical condition that makes the patient to take part in a clinical study
(congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus),
history of myocardial infarction within last 3 months, massive pleural or peritoneal
effusion; or presence of serious uncontrolled infection, diarrhea, ileus,
interstitial pneumonia, pulmonary fibrosis.

- Presence of other tumours different from basal cell carcinoma of the skin, with
disease free survival less then 3 years.

- Pregnancy or breastfeeding. In women of childbearing potential and in men, an
adequate contraceptive method must be used

- Social or psychological condition that render the patient inadequate for the
follow-up of the study

- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any
of the ingredients of the study drugs)

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy by response rate

Outcome Time Frame:

After the 3rd cycle, 6th cycle and at every follow up visit

Safety Issue:


Principal Investigator

Edibe Taylan, MD

Investigator Role:

Study Director

Investigator Affiliation:



Turkey: Ministry of Health

Study ID:




Start Date:

October 2003

Completion Date:

July 2009

Related Keywords:

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