Status:
TERMINATED
The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Advanced Non-Small Cell Lung Cancer
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either g...
Detailed Description
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00345059
Start Date
May 1 2005
End Date
May 1 2008
Last Update
January 14 2016
Active Locations (24)
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1
Azienda Ospedaliera Giovanni Paolo II
Sciacca, AG, Italy
2
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
3
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
4
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy