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Evaluation of Activity and Toxicity of Polychemotherapy With 2-Drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer


Phase 1/Phase 2
70 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

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Trial Information

Evaluation of Activity and Toxicity of Polychemotherapy With 2-Drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer


Four treatment arms are planned.

- GEMVIN: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 & 8, every 21 days

- GEMCAR: gemcitabine 1000 on days 1 & 8 and carboplatin AUC 3.5 or 4 or 4.5 on day 1,
every 21 days

- GEMCIS: gemcitabine 1000 mg/m2 on days 1 & 8 and cisplatin 50 or 60 or 70 mg/m2 on day
1, every 21 days

- GEMETO: gemcitabine 1000 mg/m2 on days 1 & 8 and etoposide 60 or 70 or 80 mg/m2 on
days 1,2,3 every 21 days

For the study of the GEMVIN combination a two-stage minimax flexible design will be applied.
For the remaining 3 combinations (GEMCAR, GEMCIS, GEMETO) a phase 1/2 design aimed at
looking for optimal dose within a Bayesian framework will be applied.


Inclusion Criteria:



- Histologic or cytologic diagnosis of SCLC

- Extensive disease

- Measurable disease

- Performance Status (ECOG) < o = 2

- Age > o = 70 years.

- Written informed consent.

Exclusion Criteria:

- Previous chemotherapy.

- Previous or concomitant malignancies (with the exception of adequately treated non
melanomatous skin cancer or carcinoma in situ of the cervix)

- •Neutrophils<2.000/mm3;platelets<100.000/mm3; hemoglobin < 10 g/dl

- Creatinine > 1.5 time the upper limit

- AST, ALT > 2.5 times and/or bilirubin > 1.5 time the upper limit of normal if liver
metastases are absent or AST, ALT ³5 times and bilirubin > 3 times the upper limit
of normal if liver metastases are present

- Symptomatic brain metastases

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:

to evaluate activity and toxicity of GEMVIN combination

Principal Investigator

Cesare Gridelli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Giuseppe Moscati Hospital, Avellino, Italy

Authority:

Italy: Ethics Committee

Study ID:

G-Step

NCT ID:

NCT00401609

Start Date:

November 2000

Completion Date:

February 2009

Related Keywords:

  • Small Cell Lung Cancer
  • elderly
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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