Clinical trial · Interventional

MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer

Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients

NCT00401492CI-TRIAL-00007407completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
gemcitabine prolonged continuous infusion	Drug	—	UNRESOLVED
vinorelbine	Drug	Vinorelbine	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (2)

measure
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
measure
Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine

Secondary outcomes (4)

measure
patient quality of life
measure
the prognostic significance of the ADL and IADL scales for time to progression and survival
measure
exploratory predictive clinical variables for chemotherapy related toxicity
measure
exploratory predictive clinical variables for response to chemotherapy

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologic or cytologic diagnosis of NSCLC
* Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
* Age \> o = 70 years.
* Written informed consent.

Exclusion Criteria:

* Performance status (ECOG) ³2
* Previous chemotherapy.
* Symptomatic brain metastases requiring synchronous radiotherapy
* Previous radiotherapy (completed less than 4 weeks before enrollment)
* Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
* Neutrophils \< 2.000/mm³ or platelets \< 100.000/mm³ or hemoglobin \< 10 g/dl.
* Serum creatinine \> 1.5 times the UNL.
* GOT and/or GPT \>1.25 times the UNL or serum total bilirubin \>1.25 times the UNL without hepatic metastases.
* GOT and/or GPT \>2.5 times the UNL or serum total bilirubin \>1.5 times the UNL with hepatic metastases.
* Other concomitant diseases contraindicating the study treatments.
* Refusal of written informed consent.
* Follow-up impossible.

References

Publications (2)

RESULTGridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, Perrone F. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol. 2007 Oct 10;25(29):4663-9. doi: 10.1200/JCO.2007.12.5708. PMID 17925563
RESULTGridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F; MILES Investigators. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer. 2008 Jul;61(1):67-72. doi: 10.1016/j.lungcan.2007.12.002. PMID 18683299