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G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

N

National Cancer Institute, Naples

Status and phase

Completed
Phase 2
Phase 1

Conditions

Small Cell Lung Cancer

Treatments

Drug: etoposide
Drug: cisplatin
Drug: gemcitabine
Drug: vinorelbine
Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer.

Full description

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.

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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