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

NCT00270582 | Unknown Phase 2

• 1 other identifier: FEMH-94015
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.weekly docetaxel plus cisplatin followed by gemcitabine and
2. 2.gemcitabine plus cisplatin followed by weekly docetaxel. Study design:Prospective, multi-center, open-labelled, randomized phase II study.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (3)

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

• weekly docetaxel plus cisplatin followed by gemcitabine and

• gemcitabine plus cisplatin followed by weekly docetaxel.

Secondary Outcomes (8)

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

• To evaluate the overall progression free survival (PFS).

• To evaluate the overall survival of each arm.

• To evaluate the time to treatment failure for first regimen.

• To evaluate the progression free survival for first regimen.

Interventions

Taxotere, Cisplatin, Gemcitabine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Histologically or cytologically proven non-small cell lung carcinoma. 3. Stage IIIB or IV disease, no curative treatment available, candidate for chemotherapy.
• \. 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.
• \. Unidimentional or bidimentional measurable disease. 8. Life expectancy \> 12 weeks. 9. Laboratory requirements :
• Hematology: Neutrophils \* 1.5 109/l, Platelets \* 100 109/l, Hemoglobin \> 10 g/dl.
• 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.
• Renal function : Creatinine \< 1 UNL, and creatinine clearance should be \> 60 ml/min.
• Complete initial lab studies within 2 weeks prior to first infusion, imaging studies within 4 weeks prior to first infusion.
• Patients must be accessible for treatment and follow-up.

You may not qualify if:

• Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.
• \. 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.
• \. Pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by NCIC-CTG criteria.
• \. Other serious illness or medical condition :
• congestive heart failure or unstable angina pectoris. High risk uncontrolled arrhythmias.
• history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
• active uncontrolled infection.
• 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.
• \. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.
• \. Concurrent treatment with any other anti-cancer therapy.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Chi-Huang Hsiao

Taipei, Ban-Ciao, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• CHI HUANG HSIAO, M.D.

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHI HUANG HSIAO, M.D.

CONTACT

886-2-89667000; onchsiao@ms28.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2005
• First Posted: December 28, 2005
• Study Start: November 1, 2005
• Last Updated: February 9, 2009

Record last verified: 2005-09

Locations

TW (1)