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A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.


Phase 2
18 Years
70 Years
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

A Multicenter, Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.


The following information on clinical trials is provided for information purposes only to
allow patients and physicians to have an initial discussion about the trial. This
information is not intended to be complete information about the trial, to contain all
considerations that may be relevant to potential participation in the trial, or to replace
the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of NSCLC istologic subtypes may
include large cell, squamous cell, or adenocarcinoma or a generic cytological
diagnosis of NSCLC;

- Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage
IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to
the revised International Staging System

- Patients must have at least one measurable lesion;

- Previous radical surgery (more 30 days before study entry) is allowed but a
pathologic proof of progression of neoplastic disease must be documented whenever
possible;

- Weight loss < = 5% within the last 3 months;

- Laboratory requirements at entry :

- Blood cell counts: Absolute neutrophils > 2.0 x 109/LPlatelets > 100 x
109/LHemoglobin > 10 g/dl

- Renal function:Serum creatinine < 1 upper normal limits (UNL). In case of limit
value of serum creatinine, the creatinine clearance should be > 60 mL/min

- Hepatic functions:Serum bilirubin < 1 x UNLASAT and ALAT < 2.5 x UNLAlkaline
phosphatase < 5 x UNL (unless accompanied by extensive bone metastases);

Exclusion criteria:

- Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant
treatments;

- Prior radiotherapy for NSCLC;

- Cyto-histological diagnosis of small cell lung cancer, carcinoid, or mixed small-cell
/ non-small cell lung cancer;

- Patients with not measurable disease only;

- Patients with symptomatic brain metastases or with leptomeningeal disease. However;
patients with symptomatic brain metastases who become asymptomatic under
corticosteriods treatment can enter the study;

- History of prior malignancies, except for cured non melanoma skin cancer, curatively
treated in situ carcinoma of the cervix or other cancer curatively treated and with
no evidence of disease for at least five years;

- History of hypersensitivity reaction to polysorbate 80;

- Pregnant or lactating women (women of childbearing potential must use adequate
contraception);

- Concurrent treatment with other experimental drugs;

- Current peripheral neuropathy NCI grade > = 2;

- Significant neurological or psychiatric disorders;

- Hepatic functions abnormalities;

- Participation in clinical trials with other experimental agents within 30 days of
study entry;

- Other serious concomitant illness of medical conditions;

- History of significant neurologic or psychiatric disorders including demential or
seizures;

- Active infection requiring iv antibiotics;

- Active ulcer, unstable diabetes mellitus or other contra-indication to
corticotherapy;

- Any other condition, which in the judgement of the investigator would place the
subject at, undoes risk or interferes with the study.

- Treatment with biphosphonates.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate

Outcome Time Frame:

Performed after 3 cycles and at the end of treatment (6 cycles).

Safety Issue:

Yes

Principal Investigator

Georges Paizis, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Italy: Ministry of Health

Study ID:

XRP6976B_2501

NCT ID:

NCT00425191

Start Date:

July 2002

Completion Date:

Related Keywords:

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

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