A Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small-Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00270582
• Date of registration: 26/12/2005
• Prospective Registration: No
• Primary sponsor: Far Eastern Memorial Hospital
• Public title: A Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small-Cell Lung Cancer
• Scientific title: A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small Cell Lung Cancer
• Date of first enrolment: November 2005
• Target sample size: 58
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00270582
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: CHI HUANG HSIAO, M.D.

• Name: CHI HUANG HSIAO, M.D.

• Name: CHI HUANG HSIAO, M.D.
• Affiliation: Far Eastern Memorial Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 1.Written informed consent prior to beginning specific protocol procedures including
expected cooperation of the patients for the treatment and follow-up, must be
obtained and documented according to the local regulatory requirements.

2. Histologically or cytologically proven non-small cell lung carcinoma. 3. Stage
IIIB or IV disease, no curative treatment available, candidate for chemotherapy.

4. Age > 18 years and < 75 years. 5. Performance status WHO performance status 0,1.
6. Previous therapy:

(a) Chemotherapy: None. (b) Previous radiation therapy : prior irradiation for NSCLC
is permitted, however, the measurable or evaluable non-measurable disease must be
completely outside the radiation portal.

7. Unidimentional or bidimentional measurable disease. 8. Life expectancy > 12 weeks.
9. Laboratory requirements :

1. Hematology: Neutrophils * 1.5 109/l, Platelets * 100 109/l, Hemoglobin > 10
g/dl.

2. Hepatic function : Total bilirubin < 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5
UNL, Alkaline phosphatases < 5 UNL ; except in presence of only bone metastasis
and in the absence of any liver disorders. Patients with ASAT and/or ALAT > 1.5
x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the
study.

3. Renal function : Creatinine < 1 UNL, and creatinine clearance should be > 60
ml/min.

10.Complete initial lab studies within 2 weeks prior to first infusion, imaging
studies within 4 weeks prior to first infusion.

11.Patients must be accessible for treatment and follow-up.

Exclusion Criteria:

- 1.Pregnant, or lactating patients; patients of childbearing potential must implement
adequate contraceptive measures during study participation.

2. Symptomatic central nervous system metastasis, patients with asymptomatic brain
metastasis can be accepted if the tumor is irradiated and do not need steroid to
control symptom.

3. Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG
criteria.

4. Other serious illness or medical condition :

1. congestive heart failure or unstable angina pectoris. High risk uncontrolled
arrhythmias.

2. history of significant neurological or psychiatric disorders including psychotic
disorders, dementia or seizures that would prohibit the understanding and giving
of informed consent.

3. active uncontrolled infection.

4. contraindication for the use of corticosteroids. 5. Past or current history of
neoplasm other than non small cell lung cancer, except for curatively treated
non melanoma skin cancer, in situ carcinoma of the cervix within 5 years.

6. Concurrent treatment with other experimental drugs. Participation in another
clinical trial with any investigational drug within 30 days prior to study
entry.

7. Concurrent treatment with any other anti-cancer therapy.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: Taxotere, Cisplatin, Gemcitabine

Primary Outcome(s)

To evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens:

gemcitabine plus cisplatin followed by weekly docetaxel.

weekly docetaxel plus cisplatin followed by gemcitabine and

Secondary Outcome(s)

To evaluate the toxicity of each arm.

To evaluate the progression free survival for first regimen.

To evaluate the time to treatment failure for first regimen.

To evaluate the duration of response.

To evaluate the overall progression free survival (PFS).

To evaluate the overall survival of each arm.

To evaluate the response rate for each regimen.

To evaluate the median overall time to treatment failure (TTF).

Secondary ID(s)

FEMH-94015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors