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Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer


Phase 3
N/A
75 Years
Not Enrolling
Both
Advanced Non-Small Cell Lung Cancer

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Trial Information

Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer


This study is for patients with previously diagnosed advanced non small cell lung cancer
(NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line
therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from
one of four treatment regimens:

- docetaxel

- docetaxel + vinorelbine

- docetaxel + gemcitabine

- docetaxel + capecitabine


Inclusion Criteria:



- Written informed consent

- Age > 18

- Histological diagnosis of non small-cell lung cancer (NSCLC)

- Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy +
radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion)

- Disease in progression

- Previous chemotherapy with platinum-derivative (and with > 21 days from last
administration)

Exclusion Criteria:

- ECOG performance status > 2

- Age > 75 years

- History of malignant neoplasm within the previous 5 years (except for baso- or
spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided
they are being adequately treated)

- Previous treatment with docetaxel

- Presence of symptomatic cerebral metastasis

- Neutrophils < 2.0 x 109/l, platelets < 100,000/l, hemoglobin > 10g/dl

- Bilirubin < 1.5 x the upper normal limit

- SGOT , SGPT, or bilirubin > 1.25 x the upper normal limits except in the presence of
hepatic metastasis

- Creatinine >1.25 x the upper normal limit

- Any concomitant pathology that would, in the Investigator's opinion, contraindicate
the use of the drugs in the protocol

- Inability to comply with follow up

- Pregnant or nursing females

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Cesare Gridelli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

S.G. Moscati Hospital, Avellino, Italy; Division of Medical Oncology

Authority:

Italy: Ethics Committee

Study ID:

DISTAL-2

NCT ID:

NCT00345059

Start Date:

May 2005

Completion Date:

May 2008

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • second line
  • monochemotherapy
  • combination chemotherapy
  • platinum refractory
  • previously treated
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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