Know Cancer

or
forgot password

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.


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

Thank you

Trial Information

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of advanced NSCLC.

- Stage III with pleural effusion and stage IV.

- Patients are 70 years old.

- Patients with 1 > ECOG PS =1.

- 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;
Leukocyte count >= 4000x10(6)/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.

- 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 to study drugs.

- 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 & 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-ANC-07

NCT ID:

NCT00905983

Start Date:

October 2007

Completion Date:

September 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Non-Small-Cell
  • Elderly patients
  • Docetaxel
  • Gemcitabine
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location