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Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of advanced NSCLC.

- Stage III with pleural effusion and stage IV.

- Patients with ECOG PS 2.

- Patients must have at least one measurable lesion, no previously irradiated.

- Life expectancy of at least 12 weeks.

- Adequate organ function according to the following criteria:

- Bone marrow: ANC => 2.0x10(9)cells/L; Platelet count => 100x10(9)cells/L;
Hemoglobin => 10 g/dL.

- Liver function: Bilirubin <= 1.5 X ULN; Alkaline phosphatase <= 5 x ULN; AST and
ALT <= 1.5 x ULN.

- Renal function:serum creatinine <= 2mg/dL.

Exclusion Criteria:

- Prior systemic chemotherapy for advanced disease.

- Prior radiotherapy for NSCLC.

- Patients with symptomatic brain metastases.

- No measurable bone metastases or malignant pleural effusion as only measurable
lesion.

- History of prior malignancies, except 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 study drugs.

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

- Concurrent treatment with other experimental drugs.

- Current peripheral neuropathy NCI grade 2.

- Participation in clinical trials within 30 days of study entry.

- Major surgery, open biopsy or traumatic lesion 28 days before to study start.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate = sum of complete and partial tumour responses divided by the number of included patients

Outcome Time Frame:

2 and 4 months

Safety Issue:

No

Principal Investigator

Oscar Juan, Doctor

Investigator Role:

Study Director

Investigator Affiliation:

Hospital Arnau de Vilanova de Valencia

Authority:

Spain: Spanish Agency of Medicines

Study ID:

CPNM-PS2-07

NCT ID:

NCT00906061

Start Date:

October 2007

Completion Date:

October 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Small Cell
  • Lung Neoplasms
  • Docetaxel
  • Gemcitabine
  • ECOG 2
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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